Baclofen
- Product NDC
- 71610-452
- 11-digit product format
- 716100452
- Labeler code
- 71610
- Product ID
- 71610-452_d28f263b-b7d3-47f4-8d3e-bc2fd5594da4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078220
- Marketing category
- ANDA
- Marketing start
- 2020-05-01
- 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 |
|---|
| 71610-452-60 | 71610045260 | 90 TABLET in 1 BOTTLE, PLASTIC (71610-452-60) | 90 tablet | 2020-07-30 | No | No | Historical |
| 71610-452-80 | 71610045280 | 180 TABLET in 1 BOTTLE, PLASTIC (71610-452-80) | 180 tablet | 2020-07-30 | No | No | Historical |
| 71610-452-92 | 71610045292 | 270 TABLET in 1 BOTTLE, PLASTIC (71610-452-92) | 270 tablet | 2020-07-30 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Baclofen | Aphena Pharma Solutions - Tennessee, LLC | 2020-08-05 | HUMAN PRESCRIPTION DRUG LABEL | 1 |