Quick answers
- What is Insulin glargine used for?
- The FDA-approved label (Lantus Solostar, sanofi-aventis U.S. LLC, June 2, 2025) says: “LANTUS is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. LANTUS is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use Not recommended for the treatment of diabetic ketoacidosis. Limitations of Use LANTUS is not recommended for the treatment of diabetic ketoacidosis.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Insulin glargine have a boxed warning?
- No. None of the 15 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Insulin glargine?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated September 1, 2026). Ask your pharmacist about alternatives.
- Has Insulin glargine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Insulin glargine?
- 6 companies list prescription products of Insulin glargine in the FDA NDC Directory, including A-S Medication Solutions, Sanofi-Aventis U.S. LLC and Biocon Biologics Inc..
What Insulin glargine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LANTUS is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. LANTUS is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use Not recommended for the treatment of diabetic ketoacidosis. Limitations of Use LANTUS is not recommended for the treatment of diabetic ketoacidosis.
— FDA label: Lantus Solostar, sanofi-aventis U.S. LLC, effective June 2, 2025. Read the full label on DailyMed →
The FDA has 15 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 15 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 22 in the FDA NDC Directory |
| Brand names | Lantus Solostar, Lantus, Semglee, Rezvoglar Kwikpen, Toujeo, Toujeo Max, Langlara, Insulin Glargine U-300, Insulin Glargine U-300 Max, Basaglar Kwikpen |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| insulin glargine 100 units/mL injection, solution | Generic | $2.90–$6.09 per mL 4 packages, lowest to highest |
| insulin glargine 100 units/mL injection, solution | Brand: BASAGLAR KwikPen | $20.92 per mL |
| insulin glargine 100 units/mL injection, solution | Brand: Lantus | $6.15 per mL |
| insulin glargine 100 units/mL injection, solution | Brand: Lantus Solostar | $6.16 per mL |
| insulin glargine 100 units/mL injection, solution | Brand: Rezvoglar KwikPen | $5.92 per mL |
| insulin glargine 100 units/mL injection, solution | Brand: Semglee | $25.74–$26.07 per mL 2 packages, lowest to highest |
| insulin glargine 300 units/mL injection, solution | Generic | $26.96–$26.99 per mL 2 packages, lowest to highest |
| insulin glargine 300 units/mL injection, solution | Brand: TOUJEO Max | $91.28 per mL |
| insulin glargine 300 units/mL injection, solution | Brand: Toujeo | $91.28 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions6 products
- Sanofi-Aventis U.S. LLC6 products
- Biocon Biologics Inc.4 products
- Civica, Inc.2 products
- Lanexa Biologics, LLC2 products
- Eli Lilly and Company2 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA021081 LANTUS, LANTUS SOLOSTAR | Sanofi Aventis Us | April 20, 2000 | 28, latest June 29, 2023 2023: Labeling · 2023: Labeling · 2022: Labeling |
| BLA205692 BASAGLAR | Eli Lilly and Co | December 16, 2015 | 8, latest July 20, 2021 2021: Labeling · 2019: Labeling · 2019: Labeling |
| BLA206538 TOUJEO MAX SOLOSTAR, TOUJEO SOLOSTAR | Sanofi Us Services | February 25, 2015 | 11, latest August 29, 2024 2024: Labeling · 2022: Labeling · 2019: Efficacy |
| BLA761201 SEMGLEE | Mylan Pharms Inc | July 28, 2021 | 3, latest November 25, 2024 2024: Labeling · 2023: Labeling · 2023: Labeling |
| BLA761215 REZVOGLAR | Eli Lilly Co | December 17, 2021 | 1, latest August 9, 2024 2024: Labeling |
| BLA761412 LANGLARA | Sunshine Lake Pharma Co Ltd | April 29, 2026 | — |
Shortage status
To be discontinued · updated September 1, 2026 · first posted September 1, 2026
| Product | Rezvoglar, Injection, 100 [iU]/1 mL (NDC 0002-8980-05) |
|---|---|
| Company | Eli Lilly and Co. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 285018, 311041, 847230, 847232, 1604539, 1604544, 1736863, 2002419, 2002420, 2268064 … (+7) |
|---|---|
| SPL set ID of the quoted label | d5e07a0c-7e14-4756-9152-9fea485d654a |
| FDA labels (SPL) | 15 |
| FDA applications | BLA021081, BLA205692, BLA206538, BLA761201, BLA761215, BLA761412 |
| Active ingredients (FDA) | INSULIN GLARGINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lantus Solostar, sanofi-aventis U.S. LLC, effective June 2, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →