BACLOFEN
- Product NDC
- 70518-4384
- 11-digit product format
- 705184384
- Labeler code
- 70518
- Product ID
- 70518-4384_3905bf7e-562c-c4ae-e063-6294a90ad12a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BACLOFEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA214374
- Marketing category
- ANDA
- Marketing start
- 2025-07-03
- 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 |
|---|
| 70518-4384-0 | 70518438400 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4384-0) | 90 tablet | 2025-07-03 | No | No | Historical |