PACK CHECK · MARKET FIRST

HumalogGeneric nameinsulin lispro

Reading size

How this medicine works

The current label describes regulation of glucose metabolism as insulin lispro's primary activity. Mechanism only supports class understanding; it cannot predict individual glucose, provide units, injection timing, meal timing or pump settings.

Read source: United States ↗reviewed 2026-08-20More about its action and precautions →

Check the market, names, dosage form and route together

A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.

Open the complete product-identity record

Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.

International brand name
Humalog
Generic name
insulin lispro
Dosage-form class
Insulin lispro injection solution: U-100 multiple-dose vial, cartridge and prefilled pens; U-200 KwikPen prefilled pen (as listed in the reviewed current U.S. label/NDC records)
Route
Subcutaneous; the U-100 label separately describes tightly controlled intravenous-infusion or pump-use contexts
Package-image status
A source-linked public label image is available below

No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.

FOR EVERYDAY QUESTIONS

After the leaflet, continue with the question you still need to check

What this pack is

Humalog is the brand name in this record; insulin lispro is the generic name. Read both together with the dosage form (injectable product).

What this page can show

This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.

What to bring to the next conversation

Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.

PRODUCT PRESENTATION IDENTITY

Strength, pack and device identity

A vial concentration, unit-per-mL value or device marking identifies the exact labelled product. It does not calculate an individual's amount, timing, administration, missed-use action, combination or switch.

U-100 and U-200 are different concentrations. Read concentration, NDC, container and device together; this page never converts personal insulin units.

6 source-backed strength, pack or device records — open the full list

First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.

United States label · DailyMed SPL v87; updated 16 Jun 2026 and published 10 Aug 2026

U-100: 100 units/mL; 10 mL multiple-dose vial

Exact display panel in the cited public label · select to enlarge
Product code
NDC 0002-7510-01
Form and route
insulin lispro injection solution · subcutaneous; intravenous only after dilution and under medical supervision
Labelled concentration
100 units/mL (U-100)Product identity, not an individual dose
Container
10 mL multiple-dose vial · 10 mL
Listing review
Current label display and NDC Directory listing reviewed 2026-08-19; actual marketing, stock and availability are not established.
insulin lispro
100 units/mLlabelled concentration; not an individual's injection units
Package
1 vial per carton
Open the presentation source ↗reviewed 2026-08-20

United States label · DailyMed SPL v87; updated 16 Jun 2026 and published 10 Aug 2026

U-100: 100 units/mL; five 3 mL cartridges

Exact display panel in the cited public label · select to enlarge
Product code
NDC 0002-7516-59
Form and route
insulin lispro injection solution · subcutaneous
Labelled concentration
100 units/mL (U-100)Product identity, not an individual dose
Container
3 mL single-patient-use cartridge · 3 mL
Compatible reusable device
HumaPen LUXURA HDThe cartridge is not itself the reusable pen.
Listing review
Current label display and NDC Directory listing reviewed 2026-08-19; actual marketing, stock and availability are not established.A separate source shows presentation status “Disc”; manual reconciliation is required.
insulin lispro
100 units/mLlabelled concentration; not an individual's injection units
Package
5 × 3 mL cartridges per carton
Open the presentation source ↗reviewed 2026-08-20

United States label · DailyMed SPL v87; updated 16 Jun 2026 and published 10 Aug 2026

U-100: 100 units/mL; five 3 mL KwikPens

Exact display panel in the cited public label · select to enlarge
Product code
NDC 0002-8799-59
Form and route
insulin lispro injection solution · subcutaneous
Labelled concentration
100 units/mL (U-100)Product identity, not an individual dose
Container
3 mL single-patient-use prefilled pen · 3 mL
Delivery device
KwikPen
Listing review
Current label display and NDC Directory listing reviewed 2026-08-19; actual marketing, stock and availability are not established.
insulin lispro
100 units/mLlabelled concentration; not an individual's injection units
Package
5 × 3 mL prefilled pens per carton
Open the presentation source ↗reviewed 2026-08-20

United States label · DailyMed SPL v87; updated 16 Jun 2026 and published 10 Aug 2026

U-100: 100 units/mL; five 3 mL Junior KwikPens

Exact display panel in the cited public label · select to enlarge
Product code
NDC 0002-7714-59
Form and route
insulin lispro injection solution · subcutaneous
Labelled concentration
100 units/mL (U-100)Product identity, not an individual dose
Container
3 mL single-patient-use prefilled pen · 3 mL
Delivery device
Junior KwikPen
Listing review
Current label display and NDC Directory listing reviewed 2026-08-19; actual marketing, stock and availability are not established.
insulin lispro
100 units/mLlabelled concentration; not an individual's injection units
Package
5 × 3 mL prefilled pens per carton
Open the presentation source ↗reviewed 2026-08-20

United States label · DailyMed SPL v87; updated 16 Jun 2026 and published 10 Aug 2026

U-100: 100 units/mL; five 3 mL Tempo Pens

Exact display panel in the cited public label · select to enlarge
Product code
NDC 0002-8213-05
Form and route
insulin lispro injection solution · subcutaneous
Labelled concentration
100 units/mL (U-100)Product identity, not an individual dose
Container
3 mL single-patient-use prefilled pen · 3 mL
Delivery device
Tempo Pen
Listing review
Current label display and NDC Directory listing reviewed 2026-08-19; actual marketing, stock and availability are not established.
insulin lispro
100 units/mLlabelled concentration; not an individual's injection units
Package
5 × 3 mL prefilled pens per carton
Open the presentation source ↗reviewed 2026-08-20

United States label · DailyMed SPL v87; updated 16 Jun 2026 and published 10 Aug 2026

U-200: 200 units/mL; two 3 mL KwikPens

Exact display panel in the cited public label · select to enlarge
Product code
NDC 0002-7712-27
Form and route
insulin lispro injection solution · subcutaneous
Labelled concentration
200 units/mL (U-200)Product identity, not an individual dose
Container
3 mL single-patient-use prefilled pen · 3 mL
Delivery device
KwikPen
Listing review
Current label display and NDC Directory listing reviewed 2026-08-19; actual marketing, stock and availability are not established.
insulin lispro
200 units/mLlabelled concentration; not an individual's injection units
Package
2 × 3 mL prefilled pens per carton
Open the presentation source ↗reviewed 2026-08-20

PUBLIC LABEL IMAGE

Appearance and package-text clues

United States · current public-label panel · exact package/label image · DailyMed SPL v87 (updated 16 Jun 2026; published 10 Aug 2026)Select the image to enlarge; press Escape to close

This current public-label package panel helps check the brand, generic name, strength and dosage-form clues only. It does not authenticate a product in hand or establish originator status, availability, sale eligibility, another package or another market.

Open the public label source ↗

LABEL READING · NOT A PRESCRIPTION

HUMALOG label reading: U-100/U-200, container and device must be checked together

Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.

This module only helps read concentration, container, NDC, volume and device in the current U.S. label; it does not generate personal injection units, meal timing, pump settings, make-up use, mixing or conversion.

  • U-100 and U-200 are different concentrations: 100 units/mL and 200 units/mL cannot be treated as the same product from “HUMALOG” or a shared 3 mL appearance. This page provides no unit conversion between them.
  • The current reviewed U-200 presentation is KwikPen only, not a vial or cartridge. The label states not to transfer U-200 from the pen into a syringe and not to use it in a pump or intravenously. If device or concentration differs, stop web inference and contact a pharmacist or prescribing team.
  • Vial, cartridge, KwikPen, Junior KwikPen and Tempo Pen are different container/device identities. A shared 3 mL or U-100 marking does not permit self-transfer, division, sharing, combining or device switching.
  • HUMALOG MIX75/25 and MIX50/50 are suspension combination products, not the HUMALOG solution in this record. If a photo or search shows MIX, protamine or suspension, do not treat this as the same dossier.
  • Hypoglycaemia with altered awareness, seizure, inability to swallow safely or another acute severe concern requires immediate local emergency support; package numbers on a webpage cannot replace emergency care or an individual plan.
Open this record's official electronic leaflet ↗

PHARMACOVIGILANCE · OFFICIAL ROUTES

Check safety information in the right market

Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.

Match five details before using a safety record

  1. Brand and generic nameBoth must match the medicine named by the record.
  2. Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
  3. Market and notice dateA record applies only to the country or region and date it names.
  4. Lot, pack and manufacturerRecord these only when the official notice specifically names them.
  5. Current product informationA historical record may have been superseded by the current label.

This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.

This dossier’s product-level source checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-20

This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.

Markets actually represented by the reviewed product documents
  • United States · 1

This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.

No dated, product-scoped official safety record is currently listed in this directory

This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.

See the reviewed safety-record directory →

Global official safety gateways

  • NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
  • FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
  • FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
  • EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
  • MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
  • PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
  • MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
  • HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
  • Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
  • TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
  • Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
  • Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
  • SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
  • WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
  • Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22

This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.

For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.

PRIVATE FAMILY LIST

Bring this record into a local medicine list

Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.

Add to the family medicine list →

PACK · LABEL · MEDICINE LIST

Six checks for this medicine pack

Use this card to organise questions about Humalog (insulin lispro). Keep the exact pack, its current label and the full medicine list together.

  1. Identify the exact product

    Humalog is the brand in this record and insulin lispro is the active-ingredient name. Check both with the dosage form (Insulin lispro injection solution: U-100 multiple-dose vial, cartridge and prefilled pens; U-200 KwikPen prefilled pen (as listed in the reviewed current U.S. label/NDC records)) and the market on the actual pack.

  2. Read the labelled strength in context

    mg/mL, mg per vial or a total volume describes the labelled concentration or pack identity of an injectable product. It is not an individual infusion amount, preparation instruction or schedule.

  3. Check the exact injection presentation

    For an injectable or infusion presentation, verify the route, concentration, container and device in the exact current label. Do not transfer, share, prepare or substitute it from this page.

  4. Put every product on one list

    Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.

  5. Ask a specific pharmacogenetics question

    Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.

  6. Know when to seek urgent help

    For a severe reaction, fainting, difficulty breathing or sudden worsening symptoms around an injection or infusion, use the local treatment team or emergency service now. Do not wait for a website reply or alter preparation, infusion or another medicine yourself.

This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.

HOW IT WORKS · NOT A TREATMENT PLAN

How insulin lispro works: supporting glucose uptake and affecting hepatic glucose output

  • Rapid action does not let a webpage decide when or how much to inject or what to do after a missed use; those questions require the exact concentration, device, prescription, monitoring record and professionals.
  • Sharing an insulin class or unit notation does not make different insulins, concentrations, pumps, vials, cartridges or pens self-equivalent, combinable or mixable.
  • Mechanism cannot replace in-person assessment of hypoglycaemia, allergy, device failure or a sharp glucose change; prioritise local urgent medical support for an acute serious concern.
Open the primary pharmacology source ↗

SOURCE EVIDENCE REGISTER

Source evidence map

Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.

SOURCE-TRACEABLE ARCHIVE

Humaloginsulin lispro

This page includes an exact current U.S. public-label package panel for Humalog, alongside documentary primary-source material. It helps check product identity, but does not itself establish originator status, product quality, availability or sale eligibility.

DOCUMENT TIMELINE

Document timeline

  1. U-100 U.S. approval node

    Current DailyMed data elements list U-100 under BLA 020563 and show a 14 Jun 1996 marketing/approval-history node; the label lists Initial U.S. Approval: 1996.

    DailyMed: current HUMALOG public label and data elements ↗
  2. U-200 BLA 205747 node

    Current DailyMed data elements list U-200 KwikPen under BLA 205747 and show a 26 May 2015 node. This does not collapse U-100 and U-200 into one concentration.

    DailyMed: current HUMALOG public label and data elements ↗
  3. Current prescribing-information revision month

    The current prescribing-information footer lists Revised 01/2026; it remains distinct from SPL effective/updated and DailyMed published dates.

    DailyMed: current HUMALOG public label ↗
  4. SPL v87 update and publication dates

    DailyMed marks the current v87 as updated/effective on 16 Jun 2026 and published on 10 Aug 2026; this page does not call both dates clinical revision dates.

    DailyMed: current HUMALOG public label ↗

MARKET SCOPE

Market-record boundary

United States

Six presentations shown in the current label and still listed in the NDC Directory are linked

Reviewed through 19 Aug 2026; the U-100 and U-200 BLA, concentration, container and device identities remain separate. This does not establish actual marketing, stock or availability; the cartridge record also has an NDC-listing versus Purple Book presentation-status discrepancy requiring separate manual review.

Mainland China, EU, Japan and other markets

Market record not established

No local trade name, approval, device, supply or interchangeability is inferred from the U.S. label.

How to read this record

Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.

Keep international and mainland China records separate

This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.

CDE listed-drug directory ↗ NMPA public query ↗

RECORD FAQ

Record questions

Can U-100 and U-200 be self-converted by volume or units?

No. This page displays product identity and provides no converter. Check the prescription, concentration, NDC and exact device with a pharmacist or prescribing team.

READ NEXT

Related reading

Evidence status

The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.

EDITORIAL RECORD

Who prepared and checked this page

Byline
OriginDrug Content Editorial
Review role
Public primary-source verification
Last reviewed
2026-08-19
Source record
1 clickable primary-source entry point is listed with this dossier.

The review role checks source traceability, stated market, document version and product-identity fields. It is not a claim of clinical licensure, prescribing authority or individual pharmacy service. Read the editorial policy.

Search records
Enlarged public-label image