Baclofen
- Product NDC
- 60687-804
- 11-digit product format
- 606870804
- Labeler code
- 60687
- Product ID
- 60687-804_3b8a78f0-cf6e-1adb-e063-6294a90a55e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA211659
- Marketing category
- ANDA
- Marketing start
- 2024-05-26
- 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 |
|---|
| 60687-804-11 | Baclofen | 1 in 1 BLISTER PACK | TABLET | 1 | | 4 |
| 60687-804-65 | Baclofen | 50 in 1 CARTON | TABLET | 50 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-804 | BACLOFEN TABLET [AMERICAN HEALTH PACKAGING] | 2 | Current NDC, 2 package rows | 20240526_8b046ee6-28fc-4ab1-b543-414ad0103e5c.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 |
|---|
| 60687-804-11 | 60687080411 | 1 in 1 BLISTER PACK | | | | | Historical |
| 60687-804-65 | 60687080465 | 50 BLISTER PACK in 1 CARTON (60687-804-65) / 1 TABLET in 1 BLISTER PACK (60687-804-11) | 50 blister pack | 2024-05-26 | No | No | Current |