Baclofen
- Product NDC
- 55289-757
- 11-digit product format
- 552890757
- Labeler code
- 55289
- Product ID
- 55289-757_419b4e87-cb86-8fbc-e063-6394a90a3b7c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA072234
- Marketing category
- ANDA
- Marketing start
- 1988-07-21
- Substance
- BACLOFEN
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 197391 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55289-757-30 | Baclofen | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 27 |
| 55289-757-60 | Baclofen | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 27 |
| 55289-757-90 | Baclofen | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 27 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Baclofen | ACTIVE INGREDIENT | H789N3FKE8 | BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| Baclofen | ACTIVE MOIETY | H789N3FKE8 | BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55289-757 | BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 26 | Current NDC, Legacy NDC, 3 package rows | 20241012_95755a7b-4a9f-45ea-a381-d3f661150efe.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 |
|---|
| 55289-757-30 | 55289075730 | 30 TABLET in 1 BOTTLE, PLASTIC (55289-757-30) | 30 tablet | 2009-03-24 | 0000-00-00 | No | No | Current |
| 55289-757-60 | 55289075760 | 60 TABLET in 1 BOTTLE, PLASTIC (55289-757-60) | 60 tablet | 2009-03-24 | 0000-00-00 | No | No | Current |
| 55289-757-90 | 55289075790 | 90 TABLET in 1 BOTTLE, PLASTIC (55289-757-90) | 90 tablet | 2007-12-26 | 0000-00-00 | No | No | Current |