Baclofen
- Product NDC
- 43063-865
- 11-digit product format
- 430630865
- Labeler code
- 43063
- Product ID
- 43063-865_415c3642-f324-746e-e063-6294a90a7ae0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA077241
- Marketing category
- ANDA
- Marketing start
- 2005-12-20
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-865-30 | Baclofen | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 26 |
| 43063-865-60 | Baclofen | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 26 |
| 43063-865-90 | Baclofen | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 26 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-865 | BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 25 | Current NDC, Legacy NDC, 3 package rows | 20241017_cfcf519f-5d15-431d-89c8-961a0c38ba60.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 |
|---|
| 43063-865-30 | 43063086530 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-865-30) | 30 tablet | 2018-06-26 | 0000-00-00 | No | No | Current |
| 43063-865-60 | 43063086560 | 60 TABLET in 1 BOTTLE, PLASTIC (43063-865-60) | 60 tablet | 2018-06-26 | 0000-00-00 | No | No | Current |
| 43063-865-90 | 43063086590 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-865-90) | 90 tablet | 2018-06-26 | 0000-00-00 | No | No | Current |