SEMGLEE
- Product NDC
- 49502-250
- 11-digit product format
- 495020250
- Labeler code
- 49502
- Product ID
- 49502-250_b9b88b11-1b0d-45c3-b9d0-fbcc2f0e2953
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- insulin glargine-yfgn
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Mylan Specialty L.P.
- Application
- BLA761201
- Marketing category
- BLA
- Marketing start
- 2021-11-15
- 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
- 2024-12-31
- 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 |
|---|
| 49502-250-80 | 49502025080 | 1 VIAL, MULTI-DOSE in 1 CARTON (49502-250-80) > 10 mL in 1 VIAL, MULTI-DOSE | 2021-11-15 | 0000-00-00 | No | No | Current |