Insulin Glargine
- Product NDC
- 12854-433
- 11-digit product format
- 128540433
- Labeler code
- 12854
- Product ID
- 12854-433_e67caa0a-67ab-febd-e053-2995a90ab343
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- insulin glargine
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Sanofi-Aventis Deutschland GmbH
- Application
- BLA021081
- Marketing category
- BLA
- Marketing start
- 2022-05-02
- Marketing end
- 0000-00-00
- Substance
- INSULIN GLARGINE
- Active strength
- 100 [iU]/mL
- Pharmacologic classes
- Insulin Analog [EPC], Insulin [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Lantus Solostar | INSULIN GLARGINE | sanofi-aventis U.S. LLC | d5e07a0c-7e14-4756-9152-9fea485d654a | 2025-06-02 | Warnings, Adverse reactions | BLA021081 |
| Insulin Glargine Solostar | INSULIN GLARGINE | A-S Medication Solutions | 9835904f-64f5-42b3-9ac9-89e4aaa5182a | 2023-11-01 | Warnings, Adverse reactions | BLA021081 |
| LANTUS SOLOSTAR | INSULIN GLARGINE | A-S Medication Solutions | 3a97c40f-0c83-42d7-a8ee-484b208db4e3 | 2023-07-22 | Warnings, Adverse reactions | BLA021081 |
| Lantus Solostar | INSULIN GLARGINE | A-S Medication Solutions | 632d9f68-f184-43d5-b184-a3af23f12ad9 | 2023-06-06 | Warnings, Adverse reactions | BLA021081 |
| Lantus | INSULIN GLARGINE | A-S Medication Solutions | ae27bb66-5dbe-4f01-a89e-f4fa7cb09c99 | 2023-02-04 | Warnings, Adverse reactions | BLA021081 |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 021081 | Lantus | insulin glargine | 351(a) | Rx | 2026-07-01 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 12854-433-01 | 12854043301 | 1 VIAL, GLASS in 1 CARTON (12854-433-01) > 10 mL in 1 VIAL, GLASS | 2022-05-02 | 0000-00-00 | No | No | Current |