Baclofen
- Product NDC
- 70710-1286
- 11-digit product format
- 707101286
- Labeler code
- 70710
- Product ID
- 70710-1286_f96d29a2-071a-4a33-a57e-bb55eba0d660
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA211659
- Marketing category
- ANDA
- Marketing start
- 2018-12-06
- Substance
- BACLOFEN
- Active strength
- 20 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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 197391, 197392, 430902, 2679605 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70710-1286-0 | Baclofen | 1000 in 1 BOTTLE | TABLET | 1000 | | 11 |
| 70710-1286-1 | Baclofen | 100 in 1 BOTTLE | TABLET | 100 | | 11 |
| 70710-1286-5 | Baclofen | 500 in 1 BOTTLE | TABLET | 500 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70710-1286 | BACLOFEN TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 11 | Current NDC, Legacy NDC, 3 package rows | 20240815_cfc49176-8d01-4c39-9319-604dd087065c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70710-1286-0 | 70710128600 | 1000 TABLET in 1 BOTTLE (70710-1286-0) | 1000 tablet | 2018-12-06 | 0000-00-00 | No | No | Current |
| 70710-1286-1 | 70710128601 | 100 TABLET in 1 BOTTLE (70710-1286-1) | 100 tablet | 2018-12-06 | 0000-00-00 | No | No | Current |
| 70710-1286-5 | 70710128605 | 500 TABLET in 1 BOTTLE (70710-1286-5) | 500 tablet | 2018-12-06 | 0000-00-00 | No | No | Current |