Baclofen
- Product NDC
- 72162-2372
- 11-digit product format
- 721622372
- Labeler code
- 72162
- Product ID
- 72162-2372_591d3710-acae-41ca-b8e2-5904e2ea8089
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA212378
- Marketing category
- ANDA
- Marketing start
- 2024-06-15
- Substance
- BACLOFEN
- Active strength
- 5 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 430902 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72162-2372-1 | Baclofen | 100 in 1 BOTTLE | TABLET | 100 | | 101 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72162-2372 | BACLOFEN TABLET [BRYANT RANCH PREPACK] | 101 | Current NDC, 1 package rows | 20241128_43cafbdb-6927-45f6-9b16-3b125cc2a29d.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 |
|---|
| 72162-2372-1 | 72162237201 | 100 TABLET in 1 BOTTLE (72162-2372-1) | 100 tablet | 2024-07-18 | No | No | Historical |