Baclofen
- Product NDC
- 70756-289
- 11-digit product format
- 707560289
- Labeler code
- 70756
- Product ID
- 70756-289_97901dd3-f1e0-4fc8-86a1-5114e2095073
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lifestar Pharma LLC
- Application
- ANDA215885
- Marketing category
- ANDA
- Marketing start
- 2022-01-26
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Baclofen
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BACLOFEN | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 197391, 197392, 430902 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70756-289-01 | Baclofen | 10 in 1 BLISTER PACK | TABLET | 10 | | 8 |
| 70756-289-11 | Baclofen | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 70756-289-12 | Baclofen | 1000 in 1 BOTTLE | TABLET | 1000 | | 8 |
| 70756-289-51 | Baclofen | 500 in 1 BOTTLE | TABLET | 500 | | 8 |
| 70756-289-99 | Baclofen | 10 in 1 CARTON | TABLET | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70756-289 | BACLOFEN TABLET [LIFESTAR PHARMA LLC] | 5 | Current NDC, Legacy NDC, 5 package rows | 20220212_f9dd1b55-2984-446a-8146-2ab0f5211e15.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 |
|---|
| 70756-289-01 | 70756028901 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 70756-289-11 | 70756028911 | 100 TABLET in 1 BOTTLE (70756-289-11) | 100 tablet | 2022-01-26 | 0000-00-00 | No | No | Current |
| 70756-289-12 | 70756028912 | 1000 TABLET in 1 BOTTLE (70756-289-12) | 1000 tablet | 2022-01-26 | 0000-00-00 | No | No | Current |
| 70756-289-51 | 70756028951 | 500 TABLET in 1 BOTTLE (70756-289-51) | 500 tablet | 2022-01-26 | 0000-00-00 | No | No | Current |
| 70756-289-99 | 70756028999 | 10 BLISTER PACK in 1 CARTON (70756-289-99) / 10 TABLET in 1 BLISTER PACK (70756-289-01) | 10 blister pack | 2024-03-25 | | No | No | Historical |