Baclofen
- Product NDC
- 68071-3468
- 11-digit product format
- 680713468
- Labeler code
- 68071
- Product ID
- 68071-3468_2ad458f9-095d-c92c-e063-6294a90ae783
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA215885
- Marketing category
- ANDA
- Marketing start
- 2022-01-26
- Substance
- BACLOFEN
- Active strength
- 10 mg/1
- Pharmacologic classes
- GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| H789N3FKE8 | BACLOFEN | 1134-47-0 | BACLOFEN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3468-3 | 68071346803 | 30 TABLET in 1 BOTTLE (68071-3468-3) | 30 tablet | 2023-08-29 | No | No | Historical |
| 68071-3468-6 | 68071346806 | 60 TABLET in 1 BOTTLE (68071-3468-6) | 60 tablet | 2023-07-24 | No | No | Historical |