BACLOFEN
- Product NDC
- 68071-3407
- 11-digit product format
- 680713407
- Labeler code
- 68071
- Product ID
- 68071-3407_2d6c67f2-f5b0-e73c-e063-6294a90a8738
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BACLOFEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA214099
- Marketing category
- ANDA
- Marketing start
- 2021-07-13
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3407-3 | BACLOFEN | 3 in 1 BOTTLE | TABLET | 3 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3407 | BACLOFEN TABLET [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, 1 package rows | 20250207_fd00fa8f-2797-c3f0-e053-6294a90a975f.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 |
|---|
| 68071-3407-3 | 68071340703 | 3 TABLET in 1 BOTTLE (68071-3407-3) | 3 tablet | 2023-05-31 | No | No | Current |