Baclofen
- Product NDC
- 58657-730
- 11-digit product format
- 586570730
- Labeler code
- 58657
- Product ID
- 58657-730_3aa113f3-27d5-328b-e063-6394a90af9e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Method Pharmaceuticals LLC
- Application
- ANDA212378
- Marketing category
- ANDA
- Marketing start
- 2024-06-15
- 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
- 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 197391, 197392, 430902 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58657-730-01 | Baclofen | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
| 58657-730-10 | Baclofen | 1000 in 1 BOTTLE | TABLET | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58657-730 | BACLOFEN TABLET [METHOD PHARMACEUTICALS LLC] | 1 | Current NDC, 2 package rows | 20240617_1a9db542-d2b0-141a-e063-6394a90acc11.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58657-730-01 | 58657073001 | 100 TABLET in 1 BOTTLE (58657-730-01) | 100 tablet | 2024-06-15 | No | No | Current |
| 58657-730-10 | 58657073010 | 1000 TABLET in 1 BOTTLE (58657-730-10) | 1000 tablet | 2024-06-15 | No | No | Current |