BACLOFEN
- Product NDC
- 85534-0004
- 11-digit product format
- 855340004
- Labeler code
- 85534
- Product ID
- 85534-0004_37457bd5-2fd0-b829-e063-6294a90a04f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BACLOFEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- HAWAII REPACK, INC.
- Application
- ANDA214099
- Marketing category
- ANDA
- Marketing start
- 2021-07-13
- Substance
- BACLOFEN
- Active strength
- 20 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 |
|---|
| 85534-0004-0 | 85534000400 | 100 TABLET in 1 BOTTLE (85534-0004-0) | 100 tablet | 2025-06-11 | No | No | Historical |
| 85534-0004-1 | 85534000401 | 120 TABLET in 1 BOTTLE (85534-0004-1) | 120 tablet | 2025-06-11 | No | No | Historical |
| 85534-0004-3 | 85534000403 | 30 TABLET in 1 BOTTLE (85534-0004-3) | 30 tablet | 2025-06-11 | No | No | Historical |
| 85534-0004-6 | 85534000406 | 60 TABLET in 1 BOTTLE (85534-0004-6) | 60 tablet | 2025-06-11 | No | No | Historical |
| 85534-0004-9 | 85534000409 | 90 TABLET in 1 BOTTLE (85534-0004-9) | 90 tablet | 2025-06-11 | No | No | Historical |