SEMGLEE
- Product NDC
- 50090-5835
- 11-digit product format
- 500905835
- Labeler code
- 50090
- Product ID
- 50090-5835_243d739f-8628-44e1-bad0-1d9a01a55f2b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- insulin glargine
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- A-S Medication Solutions
- Application
- BLA210605
- Marketing category
- BLA
- Marketing start
- 2020-08-31
- Marketing end
- 0000-00-00
- Substance
- INSULIN GLARGINE
- Active strength
- 100 [iU]/mL
- Pharmacologic classes
- Insulin [CS],Insulin Analog [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-5835-0 | 50090583500 | 1 VIAL in 1 CARTON (50090-5835-0) > 10 mL in 1 VIAL | 1 vial | 2021-10-28 | 0000-00-00 | No | No | Current |