BACLOFEN
- Product NDC
- 71335-9638
- 11-digit product format
- 713359638
- Labeler code
- 71335
- Product ID
- 71335-9638_1223f677-9ada-40f3-8eb2-aa61fe18d50a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BACLOFEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA209102
- Marketing category
- ANDA
- Marketing start
- 2018-04-01
- 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 |
|---|
| 71335-9638-0 | 71335963800 | 112 TABLET in 1 BOTTLE (71335-9638-0) | 112 tablet | 2024-05-30 | No | No | Historical |
| 71335-9638-1 | 71335963801 | 30 TABLET in 1 BOTTLE (71335-9638-1) | 30 tablet | 2023-03-16 | No | No | Historical |
| 71335-9638-2 | 71335963802 | 120 TABLET in 1 BOTTLE (71335-9638-2) | 120 tablet | 2023-05-24 | No | No | Historical |
| 71335-9638-3 | 71335963803 | 20 TABLET in 1 BOTTLE (71335-9638-3) | 20 tablet | 2023-12-21 | No | No | Historical |
| 71335-9638-4 | 71335963804 | 60 TABLET in 1 BOTTLE (71335-9638-4) | 60 tablet | 2023-03-24 | No | No | Historical |
| 71335-9638-5 | 71335963805 | 100 TABLET in 1 BOTTLE (71335-9638-5) | 100 tablet | 2024-05-30 | No | No | Historical |
| 71335-9638-6 | 71335963806 | 56 TABLET in 1 BOTTLE (71335-9638-6) | 56 tablet | 2024-05-30 | No | No | Historical |
| 71335-9638-7 | 71335963807 | 90 TABLET in 1 BOTTLE (71335-9638-7) | 90 tablet | 2023-04-03 | No | No | Historical |
| 71335-9638-8 | 71335963808 | 140 TABLET in 1 BOTTLE (71335-9638-8) | 140 tablet | 2024-05-30 | No | No | Historical |
| 71335-9638-9 | 71335963809 | 84 TABLET in 1 BOTTLE (71335-9638-9) | 84 tablet | 2024-05-30 | No | No | Historical |