Insulin Glargine
- Product NDC
- 0955-1729
- 11-digit product format
- 009551729
- Labeler code
- 0955
- Product ID
- 0955-1729_e2de84cb-b6eb-44b6-85ee-cc57bb3080dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- insulin glargine
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Winthrop U.S.
- 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0955-1729 | INSULIN GLARGINE INJECTION, SOLUTION INSULIN GLARGINE SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [WINTHROP U.S.] | 9 | Legacy NDC | 20240104_406883ea-7f97-4eff-8d43-0bab004654f1.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0955-1729-01 | 00955172901 | 1 VIAL, GLASS in 1 CARTON (0955-1729-01) > 10 mL in 1 VIAL, GLASS | 2022-05-02 | 0000-00-00 | No | No | Current |