BACLOFEN
- Product NDC
- 72865-296
- 11-digit product format
- 728650296
- Labeler code
- 72865
- Product ID
- 72865-296_2d6876fe-19e5-fd4f-e063-6294a90a7960
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BACLOFEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- XLCare Pharmaceuticals Inc.
- Application
- ANDA212378
- Marketing category
- ANDA
- Marketing start
- 2025-02-05
- 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 |
|---|
| 72865-296-01 | BACLOFEN | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72865-296 | BACLOFEN TABLET BACLOFEN (BACLOFEN) TABLET [XLCARE PHARMACEUTICALS INC.] | 2 | Current NDC, 1 package rows | 20250207_2b4908fb-47b5-4675-be9e-ca1ad48a7252.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 |
|---|
| 72865-296-01 | 72865029601 | 100 TABLET in 1 BOTTLE (72865-296-01) | 100 tablet | 2025-02-05 | No | No | Current |