Baclofen
- Product NDC
- 71335-2668
- 11-digit product format
- 713352668
- Labeler code
- 71335
- Product ID
- 71335-2668_5550f869-5447-421b-9697-e8103b114fb8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA212378
- Marketing category
- ANDA
- Marketing start
- 2024-06-15
- 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
- 71335-2668_5550f869-5447-421b-9697-e8103b114fb8
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Baclofen
- Generic name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2024-06-15
- Marketing category
- ANDA
- Application number
- ANDA212378
- 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 | a748da19-d3eb-499e-986c-2043a1356f2b |
| 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 | Sample | Exclude flag | Status |
|---|
| 71335-2668-0 | 71335266800 | 120 TABLET in 1 BOTTLE (71335-2668-0) | 120 tablet | 2025-07-15 | No | No | Current |
| 71335-2668-1 | 71335266801 | 90 TABLET in 1 BOTTLE (71335-2668-1) | 90 tablet | 2025-07-15 | No | No | Current |
| 71335-2668-2 | 71335266802 | 20 TABLET in 1 BOTTLE (71335-2668-2) | 20 tablet | 2025-07-15 | No | No | Current |
| 71335-2668-3 | 71335266803 | 60 TABLET in 1 BOTTLE (71335-2668-3) | 60 tablet | 2025-07-15 | No | No | Current |
| 71335-2668-4 | 71335266804 | 45 TABLET in 1 BOTTLE (71335-2668-4) | 45 tablet | 2025-07-15 | No | No | Current |
| 71335-2668-5 | 71335266805 | 112 TABLET in 1 BOTTLE (71335-2668-5) | 112 tablet | 2025-07-15 | No | No | Current |
| 71335-2668-6 | 71335266806 | 30 TABLET in 1 BOTTLE (71335-2668-6) | 30 tablet | 2025-07-15 | No | No | Current |
| 71335-2668-7 | 71335266807 | 56 TABLET in 1 BOTTLE (71335-2668-7) | 56 tablet | 2025-07-15 | No | No | Current |
| 71335-2668-8 | 71335266808 | 15 TABLET in 1 BOTTLE (71335-2668-8) | 15 tablet | 2025-07-15 | No | No | Current |
| 71335-2668-9 | 71335266809 | 84 TABLET in 1 BOTTLE (71335-2668-9) | 84 tablet | 2025-07-15 | No | No | Current |