Baclofen
- Product NDC
- 63629-2084
- 11-digit product format
- 636292084
- Labeler code
- 63629
- Product ID
- 63629-2084_e8875fbb-0e8e-43ea-b904-f15d00931b9c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA077241
- Marketing category
- ANDA
- Marketing start
- 2005-12-20
- 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 |
|---|
| 63629-2084-1 | 63629208401 | 100 TABLET in 1 BOTTLE (63629-2084-1) | 100 tablet | 2005-12-20 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Baclofen Tablets, USP | Bryant Ranch Prepack | 2023-10-20 | HUMAN PRESCRIPTION DRUG LABEL | 103 |