BACLOFEN
- Product NDC
- 0904-7552
- 11-digit product format
- 009047552
- Labeler code
- 0904
- Product ID
- 0904-7552_5c3857ec-f6de-489c-909d-79cad21f784e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA215885
- Marketing category
- ANDA
- Marketing start
- 2025-11-01
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BACLOFEN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BACLOFEN | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 197391, 197392 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7552-61 | BACLOFEN | 10 in 1 BLISTER PACK | TABLET | 10 | | 1 |
| 0904-7552-61 | BACLOFEN | 10 in 1 CARTON | TABLET | 10 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7552-61 | 00904755261 | 10 BLISTER PACK in 1 CARTON (0904-7552-61) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2025-11-01 | No | No | Current |