Baclofen
- Product NDC
- 71610-921
- 11-digit product format
- 716100921
- Labeler code
- 71610
- Product ID
- 71610-921_3981d8b6-57a3-9e62-e063-6394a90a36c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA215885
- Marketing category
- ANDA
- Marketing start
- 2022-01-25
- 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
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 |
|---|
| 71610-921-60 | 71610092160 | 90 TABLET in 1 BOTTLE (71610-921-60) | 90 tablet | 2025-07-08 | No | No | Historical |
| 71610-921-92 | 71610092192 | 270 TABLET in 1 BOTTLE (71610-921-92) | 270 tablet | 2025-07-08 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Baclofen Tablets, USP Rx only | Aphena Pharma Solutions - Tennessee, LLC | 2025-07-09 | HUMAN PRESCRIPTION DRUG LABEL | 1 |