Baclofen
- Product NDC
- 70771-1586
- 11-digit product format
- 707711586
- Labeler code
- 70771
- Product ID
- 70771-1586_2c2eb58e-8920-43f4-aaa9-6f5add3b35ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA211659
- Marketing category
- ANDA
- Marketing start
- 2020-05-07
- 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, 2679605 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70771-1586-1 | Baclofen | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1586 | BACLOFEN TABLET [ZYDUS LIFESCIENCES LIMITED] | 8 | Current NDC, Legacy NDC, 1 package rows | 20240815_bb5c6faa-2933-44d1-8706-8302150be734.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 |
|---|
| 70771-1586-1 | 70771158601 | 100 TABLET in 1 BOTTLE (70771-1586-1) | 100 tablet | 2020-05-07 | 0000-00-00 | No | No | Current |