Baclofen
- Product NDC
- 67544-671
- 11-digit product format
- 675440671
- Labeler code
- 67544
- Product ID
- 67544-671_ba0a7c8f-e018-4e0b-97df-8e5752eb03ad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA077156
- Marketing category
- ANDA
- Marketing start
- 2005-08-30
- 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 |
|---|
| 67544-671-60 | 67544067160 | 90 TABLET in 1 BOTTLE, PLASTIC (67544-671-60) | 90 tablet | 2006-09-14 | No | No | Historical |
| 67544-671-80 | 67544067180 | 180 TABLET in 1 BOTTLE, PLASTIC (67544-671-80) | 180 tablet | 2008-07-28 | No | No | Historical |
| 67544-671-92 | 67544067192 | 270 TABLET in 1 BOTTLE, PLASTIC (67544-671-92) | 270 tablet | 2008-07-28 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Baclofen Tablets, USP | Aphena Pharma Solutions - Tennessee, LLC | 2017-12-07 | HUMAN PRESCRIPTION DRUG LABEL | 1 |