SEMGLEE
- Product NDC
- 49502-251
- 11-digit product format
- 495020251
- Labeler code
- 49502
- Product ID
- 49502-251_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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49502-251-35 | 49502025135 | 1 SYRINGE in 1 CARTON (49502-251-35) > 3 mL in 1 SYRINGE | 1 syringe | 2022-10-01 | 0000-00-00 | Yes | No | Current |
| 49502-251-71 | 49502025171 | 1 SYRINGE in 1 CARTON (49502-251-71) > 3 mL in 1 SYRINGE | 1 syringe | 2022-10-01 | 0000-00-00 | No | No | Current |
| 49502-251-73 | 49502025173 | 3 SYRINGE in 1 CARTON (49502-251-73) > 3 mL in 1 SYRINGE | 3 syringe | 2022-10-01 | 0000-00-00 | No | No | Current |
| 49502-251-75 | 49502025175 | 5 SYRINGE in 1 CARTON (49502-251-75) > 3 mL in 1 SYRINGE | 5 syringe | 2021-11-15 | 0000-00-00 | No | No | Current |
| 49502-251-98 | 49502025198 | 3 SYRINGE in 1 CARTON (49502-251-98) > 3 mL in 1 SYRINGE | 3 syringe | 2022-10-01 | 0000-00-00 | Yes | No | Current |
| 49502-251-99 | 49502025199 | 5 SYRINGE in 1 CARTON (49502-251-99) > 3 mL in 1 SYRINGE | 5 syringe | 2022-10-01 | 0000-00-00 | Yes | No | Current |