BACLOFEN
- Product NDC
- 0904-7558
- 11-digit product format
- 009047558
- Labeler code
- 0904
- Product ID
- 0904-7558_f4cd8d66-4b60-4e2c-89e1-6c897fb9431d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BACLOFEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA209102
- Marketing category
- ANDA
- Marketing start
- 2025-10-22
- Substance
- BACLOFEN
- Active strength
- 5 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BACLOFEN
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BACLOFEN | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 430902 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7558-06 | BACLOFEN | 1 in 1 BLISTER PACK | TABLET | 1 | | 3 |
| 0904-7558-06 | BACLOFEN | 50 in 1 CARTON | TABLET | 50 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7558-06 | 00904755806 | 50 BLISTER PACK in 1 CARTON (0904-7558-06) / 1 TABLET in 1 BLISTER PACK | 50 blister pack | 2025-10-22 | No | No | Current |