Baclofen
- Product NDC
- 80425-0157
- 11-digit product format
- 804250157
- Labeler code
- 80425
- Product ID
- 80425-0157_2a99a7f4-89e8-19db-e063-6294a90a90da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA209102
- Marketing category
- ANDA
- Marketing start
- 2021-07-30
- 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 | 197392 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0157-1 | Baclofen | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
| 80425-0157-2 | Baclofen | 60 in 1 BOTTLE | TABLET | 60 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0157 | BACLOFEN TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250101_c85a9d82-1d61-aeec-e053-2995a90a03a4.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 |
|---|
| 80425-0157-1 | 80425015701 | 30 TABLET in 1 BOTTLE (80425-0157-1) | 30 tablet | 2021-07-30 | 0000-00-00 | No | No | Current |
| 80425-0157-2 | 80425015702 | 60 TABLET in 1 BOTTLE (80425-0157-2) | 60 tablet | 2021-07-30 | 0000-00-00 | No | No | Current |