What this pack is
Lantus is the brand name in this record; insulin glargine is the generic name. Read both together with the dosage form (injectable product).
PACK CHECK · MARKET FIRST
LantusGeneric nameinsulin glargine
Mainland China pack-name cue来得时®Historical or public source cue · verify the current target-market record · Open reference ↗
How this medicine works
The FDA public label describes insulin glargine's primary activity as regulating glucose metabolism: it stimulates peripheral glucose uptake, especially in skeletal muscle and fat, and inhibits hepatic glucose production. This explains a pathway; it does not give individual units, injection timing, switching or hypoglycaemia-management plans.
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.
- Mainland China pack-name cue
- 来得时®
- International brand name
- Lantus
- Generic name
- insulin glargine
- Dosage-form class
- Subcutaneous insulin glargine injection: U-100 10 mL multiple-dose vial and 3 mL SoloStar single-patient-use prefilled pen are distinct package/device presentations (as listed in the current U.S. label)
- Route
- Subcutaneous use (individual use requires professional review)
- Package-image status
- A source-linked public label image is available below
Mainland China trade-name search cue:来得时®. This is a historical/public cue for reading pack text. It does not establish current approval, holder, supply or sale eligibility. Open reference ↗
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
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.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
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.
2 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 · Prescribing information revised May 2025; DailyMed SPL v35 published 2 Jul 2025
100 units/mL (U-100); 10 mL multiple-dose vial; 1 vial per carton
- Product code
- NDC 0088-2220-33
- Form and route
- LANTUS insulin glargine injection · subcutaneous use (label scope; this page does not determine an individual's injection units or timing)
- Labelled concentration
- 100 units/mL (U-100; labelled concentration, not an individual injection amount)Product identity, not an individual dose
- Container
- 10 mL multiple-dose vial; 1 vial per carton · 10 mL
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-21; actual marketing, stock and availability are not established.
- insulin glargine
- 100 units/mLlabelled concentration; not an individual's injection units, dose or switching rule
- Package
- 1 vial per carton
United States label · Prescribing information revised May 2025; DailyMed SPL v35 published 2 Jul 2025
100 units/mL (U-100); 3 mL SoloStar single-patient-use prefilled pen; 5 pens per carton
- Product code
- NDC 0088-2219-05
- Form and route
- LANTUS insulin glargine injection · subcutaneous use (label scope; this page does not determine an individual's injection units or timing)
- Labelled concentration
- 100 units/mL (U-100; labelled concentration, not an individual injection amount)Product identity, not an individual dose
- Container
- 3 mL SoloStar single-patient-use prefilled pen; 5 pens per carton · 3 mL
- Delivery device
- SoloStar
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-21; actual marketing, stock and availability are not established.
- insulin glargine
- 100 units/mLlabelled concentration; not an individual's injection units, dose or switching rule
- Package
- 5 × pens per carton
PUBLIC LABEL IMAGE
Appearance and package-text clues
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
LANTUS label reading: units, concentration and delivery device cannot be reduced to one number
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 uses U.S. FDA and DailyMed public labels as reading entry points for LANTUS, insulin glargine, 100 units/mL (U-100), the subcutaneous route and vial/prefilled-pen presentations. It does not generate individual injection units, switching, mixing or glucose-management plans.
- “100 units/mL (U-100)” describes the concentration of the labelled product. Units and mg are not one unit that can be converted from a webpage. A dose-window display, the actual units used and product concentration must be checked together against the exact device, prescription and current label with a clinician or pharmacist.
- The public archive includes wording for different presentations such as vials and prefilled pens. They are part of product identity. Do not apply experience with another pen, vial or insulin to this product, or self-convert, substitute or mix products from appearance or a shared insulin-glargine name.
- The label tells patients to check the insulin label before each injection to reduce medication errors, and notes that regimen changes can alter hyperglycaemia or hypoglycaemia risk and need close professional supervision. With confusion, a product change, abnormal glucose results or symptoms, contact the care team with the actual pack and complete medicine list rather than waiting for a website adjustment answer.
- A pack image, brand name or “long-acting” description cannot authenticate a product, prove interchangeability or decide an individual's injection timing or units. This page does not replace teaching with the actual device; seek an in-person check and demonstration from a pharmacist, nurse or clinician if reading, vision, memory or handling is difficult.
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
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- 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.
This record’s label or product-record routeDailyMed (NLM): current U.S. LANTUS insulin glargine label (sanofi-aventis U.S.; SPL v35, published 2 Jul 2025) ↗reviewed 2026-08-20
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 Lantus (insulin glargine). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
Lantus is the brand in this record and insulin glargine is the active-ingredient name. Check both with the dosage form (Subcutaneous insulin glargine injection: U-100 10 mL multiple-dose vial and 3 mL SoloStar single-patient-use prefilled pen are distinct package/device presentations (as listed in the current U.S. label)) and the market on the actual pack.
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.
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.
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.
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.
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 glargine works: it affects glucose use and hepatic glucose production
- Mechanism is not a “unit formula.” The 100 units/mL on a pack is concentration, and U (units) is not the same unit as mg for webpage conversion; the actual units used, product concentration and device must be checked together against the exact prescription and current label.
- Being insulins or both described as “long-acting” does not make products, devices or monitoring requirements the same. Do not self-substitute, mix or adjust from a shared mechanism, appearance or fragment of a name.
- With abnormal glucose readings, feeling unwell, a different pack or uncertainty reading a device, a webpage mechanism explanation cannot decide the next step. Take the actual product and full medicine list to the care team or pharmacist for review.
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
Lantusinsulin glargine
This page includes an exact current U.S. public-label package panel for Lantus, 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
Initial U.S. approval year listed in the current label
The current LANTUS label lists Initial U.S. Approval: 2000. This year locates this U.S. label record only; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in Mainland China, the EU, Japan or another market.
DailyMed (NLM): current U.S. LANTUS insulin glargine label (sanofi-aventis U.S.; SPL v35, published 2 Jul 2025) ↗Current public SPL v35 published on DailyMed
DailyMed lists 2 Jul 2025 as the publication date for current LANTUS SPL v35. This page separately displays one exact U-100 10 mL multiple-dose vial panel and one U-100 3 mL SoloStar single-patient-use prefilled-pen panel; it does not establish actual availability, stock, individual injection units, injection timing, mixing, switching or another-package status.
DailyMed (NLM): current U.S. LANTUS insulin glargine label (sanofi-aventis U.S.; SPL v35, published 2 Jul 2025) ↗
MARKET SCOPE
Market-record boundary
United States
Current label, 10 mL vial and 3 mL SoloStar exact package panels linkedThe package panels correspond respectively to NDC 0088-2220-33 vial and NDC 0088-2219-05 SoloStar prefilled pen. They do not authenticate a product or establish actual availability, stock, individual units, injection timing, mixing or interchangeability.
Mainland China, EU, Japan and other markets
Market record not establishedNo local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label or brand name; every market version needs separate checking against current local regulatory information.
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.
Mainland China trade-name search cue: 来得时®
This cue helps read packaging and search official records. It does not establish current approval, holder, strength, originator relationship, supply or sale eligibility. Open historical reference ↗
RECORD FAQ
Record questions
Can U-100, a 10 mL vial and a 3 mL SoloStar prefilled pen be exchanged from a number or a shared insulin-glargine name alone?
No. U-100 is the label's concentration notation, while the 10 mL vial and 3 mL SoloStar prefilled pen are different package/device identities. A shared generic name, matching concentration or package image does not establish self-switching, mixing, unit adjustment or a timing change; have a pharmacist or prescribing team review the actual product, prescription and complete medicine list.
Why does the page emphasise checking the label but not provide individual units or switching steps?
The current label notes that changes in an insulin regimen may affect hyperglycaemia or hypoglycaemia risk and need close professional supervision. This page helps identify the exact package, concentration and source, then routes individual questions back to the care team; it is not a tool for dosing, switching, mixing or glucose management.
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.