Baclofen
- Product NDC
- 72189-565
- 11-digit product format
- 721890565
- Labeler code
- 72189
- Product ID
- 72189-565_1bf59c3b-f8ec-972e-e063-6394a90aeccc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct_rx
- Application
- ANDA214374
- Marketing category
- ANDA
- Marketing start
- 2024-06-28
- 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 |
|---|
| 72189-565-60 | 72189056560 | 60 TABLET in 1 BOTTLE (72189-565-60) | 60 tablet | 2024-06-28 | No | No | Historical |
| 72189-565-82 | 72189056582 | 180 TABLET in 1 BOTTLE (72189-565-82) | 180 tablet | 2024-06-28 | No | No | Historical |
| 72189-565-90 | 72189056590 | 90 TABLET in 1 BOTTLE (72189-565-90) | 90 tablet | 2024-06-28 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Baclofen | Direct_rx | 2024-06-28 | HUMAN PRESCRIPTION DRUG LABEL | 1 |