SEMGLEE
- Product NDC
- 49502-196
- 11-digit product format
- 495020196
- Labeler code
- 49502
- Product ID
- 49502-196_2ed619e6-67e7-402e-a3bc-7cd7b81d59bf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- insulin glargine
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Mylan Specialty L.P.
- Application
- BLA210605
- Marketing category
- BLA
- Marketing start
- 2020-08-31
- Marketing end
- 2022-11-30
- Substance
- INSULIN GLARGINE
- Active strength
- 100 [iU]/mL
- Pharmacologic classes
- Insulin [CS],Insulin Analog [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 |
|---|
| 49502-196-75 | 49502019675 | 5 SYRINGE in 1 CARTON (49502-196-75) > 3 mL in 1 SYRINGE (49502-196-35) | 5 syringe | 2020-08-31 | 2022-11-30 | No | No | Current |