Baclofen
- Product NDC
- 50090-6868
- 11-digit product format
- 500906868
- Labeler code
- 50090
- Product ID
- 50090-6868_c472fde4-c4d2-4ae7-978a-469fbc5ebe2e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA074584
- Marketing category
- ANDA
- Marketing start
- 2010-10-20
- 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 |
|---|
| 50090-6868-0 | 50090686800 | 60 TABLET in 1 BOTTLE (50090-6868-0) | 60 tablet | 2023-12-04 | No | No | Historical |
| 50090-6868-1 | 50090686801 | 30 TABLET in 1 BOTTLE (50090-6868-1) | 30 tablet | 2023-12-04 | No | No | Historical |
| 50090-6868-3 | 50090686803 | 90 TABLET in 1 BOTTLE (50090-6868-3) | 90 tablet | 2023-12-04 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| BACLOFEN TABLETS, USP | A-S Medication Solutions | 2023-12-05 | HUMAN PRESCRIPTION DRUG LABEL | 1 |