BACLOFEN
- Product NDC
- 50090-7601
- 11-digit product format
- 500907601
- Labeler code
- 50090
- Product ID
- 50090-7601_b58c4e65-de1f-4199-af80-561e2149278f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BACLOFEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA209102
- Marketing category
- ANDA
- Marketing start
- 2018-04-01
- 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 |
|---|
| 50090-7601-0 | 50090760100 | 90 TABLET in 1 BOTTLE (50090-7601-0) | 90 tablet | 2025-07-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| BACLOFEN TABLETS, USP | A-S Medication Solutions | 2025-07-15 | HUMAN PRESCRIPTION DRUG LABEL | 1 |