Baclofen
- Product NDC
- 0904-6475
- 11-digit product format
- 009046475
- Labeler code
- 0904
- Product ID
- 0904-6475_9b1e8651-0d74-4a7a-a35f-480c94a4ecc0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA078220
- Marketing category
- ANDA
- Marketing start
- 2015-07-15
- Marketing end
- 2027-05-31
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Baclofen
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 |
|---|
| 0904-6475-61 | Baclofen | 1 in 1 BLISTER PACK | TABLET | 1 | | 11 |
| 0904-6475-61 | Baclofen | 100 in 1 CARTON | TABLET | 100 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6475 | BACLOFEN TABLET [MAJOR PHARMACEUTICALS] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250210_ae732bdc-5178-4565-8219-d1787a5211a6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-6475-61 | 00904647561 | 100 BLISTER PACK in 1 CARTON (0904-6475-61) / 1 TABLET in 1 BLISTER PACK | 100 blister pack | 2015-07-15 | 2027-05-31 | No | No | Current |