BACLOFEN
- Product NDC
- 50090-7600
- 11-digit product format
- 500907600
- Labeler code
- 50090
- Product ID
- 50090-7600_7a2d22d8-d07b-4783-b16e-01ee5ac7286b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BACLOFEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA209102
- Marketing category
- ANDA
- Marketing start
- 2018-04-01
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-7600-0 | BACLOFEN | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
| 50090-7600-1 | BACLOFEN | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 50090-7600-3 | BACLOFEN | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7600-0 | 50090760000 | 60 TABLET in 1 BOTTLE (50090-7600-0) | 60 tablet | 2025-07-14 | No | No | Current |
| 50090-7600-1 | 50090760001 | 30 TABLET in 1 BOTTLE (50090-7600-1) | 30 tablet | 2025-07-14 | No | No | Current |
| 50090-7600-3 | 50090760003 | 90 TABLET in 1 BOTTLE (50090-7600-3) | 90 tablet | 2025-07-14 | No | No | Current |