BACLOFEN
- Product NDC
- 72888-202
- 11-digit product format
- 728880202
- Labeler code
- 72888
- Product ID
- 72888-202_490e18d8-694e-da7b-e063-6294a90ab450
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BACLOFEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advagen Pharma Limited
- Application
- ANDA209102
- Marketing category
- ANDA
- Marketing start
- 2024-02-05
- Substance
- BACLOFEN
- Active strength
- 15 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
- 2027-12-31
- 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 |
|---|
| 72888-202-00 | 72888020200 | 1000 TABLET in 1 BOTTLE (72888-202-00) | 1000 tablet | 2024-02-05 | No | No | Historical |
| 72888-202-01 | 72888020201 | 100 TABLET in 1 BOTTLE (72888-202-01) | 100 tablet | 2024-02-05 | No | No | Historical |
| 72888-202-05 | 72888020205 | 500 TABLET in 1 BOTTLE (72888-202-05) | 500 tablet | 2024-02-05 | No | No | Historical |
| 72888-202-30 | 72888020230 | 30 TABLET in 1 BOTTLE (72888-202-30) | 30 tablet | 2024-02-05 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| BACLOFEN TABLETS, USP | Advagen Pharma Limited | Rubicon Research Limited | 2026-01-23 | HUMAN PRESCRIPTION DRUG LABEL | 7 |