Baclofen
- Product NDC
- 70771-1449
- 11-digit product format
- 707711449
- Labeler code
- 70771
- Product ID
- 70771-1449_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
- 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 |
|---|
| 70771-1449-0 | Baclofen | 1000 in 1 BOTTLE | TABLET | 1000 | | 8 |
| 70771-1449-1 | Baclofen | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 70771-1449-5 | Baclofen | 500 in 1 BOTTLE | TABLET | 500 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1449 | BACLOFEN TABLET [ZYDUS LIFESCIENCES LIMITED] | 8 | Current NDC, Legacy NDC, 3 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 |
|---|
| 70771-1449-0 | 70771144900 | 1000 TABLET in 1 BOTTLE (70771-1449-0) | 1000 tablet | 2018-12-06 | 0000-00-00 | No | No | Current |
| 70771-1449-1 | 70771144901 | 100 TABLET in 1 BOTTLE (70771-1449-1) | 100 tablet | 2018-12-06 | 0000-00-00 | No | No | Current |
| 70771-1449-5 | 70771144905 | 500 TABLET in 1 BOTTLE (70771-1449-5) | 500 tablet | 2018-12-06 | 0000-00-00 | No | No | Current |