Baclofen
- Product NDC
- 50090-6869
- 11-digit product format
- 500906869
- Labeler code
- 50090
- Product ID
- 50090-6869_624a0565-ee42-4f30-a23e-825ae6ae6709
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA074584
- Marketing category
- ANDA
- Marketing start
- 2010-10-20
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-6869-0 | Baclofen | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-6869 | BACLOFEN TABLET [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 1 package rows | 20231207_e163e7dc-45a5-43c2-b13d-a4453f2c360c.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 |
|---|
| 50090-6869-0 | 50090686900 | 90 TABLET in 1 BOTTLE (50090-6869-0) | 90 tablet | 2023-12-04 | No | No | Current |