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
Packages#
Package NDC, 11-digit format, Description table| 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 |