BACLOFEN
- Product NDC
- 72789-508
- 11-digit product format
- 727890508
- Labeler code
- 72789
- Product ID
- 72789-508_4e06128d-0ec0-8b3f-e063-6294a90a721c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BACLOFEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA209102
- Marketing category
- ANDA
- Marketing start
- 2018-04-01
- 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
- 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 | 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 |
|---|
| 72789-508-30 | BACLOFEN | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 4 |
| 72789-508-90 | BACLOFEN | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-508 | BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.] | 2 | Current NDC, 2 package rows | 20250515_ee59a379-17d5-487f-b72f-a53e74744a70.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-508-30 | 72789050830 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-508-30) | 30 tablet | 2025-05-13 | No | No | Current |
| 72789-508-90 | 72789050890 | 90 TABLET in 1 BOTTLE, PLASTIC (72789-508-90) | 90 tablet | 2025-05-13 | No | No | Current |