Baclofen
- Product NDC
- 63629-2130
- 11-digit product format
- 636292130
- Labeler code
- 63629
- Product ID
- 63629-2130_ccaebbf5-6a33-481c-b4d2-77607d10c62b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA077068
- Marketing category
- ANDA
- Marketing start
- 2005-08-30
- 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
openFDA Listing Details
- Product ID
- 63629-2130_ccaebbf5-6a33-481c-b4d2-77607d10c62b
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Baclofen
- Generic name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2005-08-30
- Marketing category
- ANDA
- Application number
- ANDA077068
- Pharmacologic classes
- GABA A Agonists [MoA]; GABA B Agonists [MoA]; gamma-Aminobutyric Acid-ergic Agonist [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| BACLOFEN | 20 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 197392 |
| Spl Set Id | e13c0563-0f32-4199-acb0-ad2376ec951b |
| Manufacturer Name | Bryant Ranch Prepack |
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-2130-1 | 63629213001 | 1000 TABLET in 1 BOTTLE, PLASTIC (63629-2130-1) | 1000 tablet | 2005-08-30 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| BACLOFEN TABLETS, USP | Bryant Ranch Prepack | 2024-12-05 | HUMAN PRESCRIPTION DRUG LABEL | 104 |