Baclofen
- Product NDC
- 71335-1797
- 11-digit product format
- 713351797
- Labeler code
- 71335
- Product ID
- 71335-1797_081609c5-fd3c-45d1-e063-6394a90a3e2d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA212378
- Marketing category
- ANDA
- Marketing start
- 2020-10-09
- 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#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1797 | BACLOFEN TABLET [BRYANT RANCH PREPACK] | 101 | Current NDC, Legacy NDC, 10 package rows | 20231020_f9cf294a-85d1-4321-af68-4279b20c4b71.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 |
|---|
| 71335-1797-0 | 71335179700 | 112 TABLET in 1 BOTTLE (71335-1797-0) | 112 tablet | 2021-12-20 | 0000-00-00 | No | No | Current |
| 71335-1797-1 | 71335179701 | 30 TABLET in 1 BOTTLE (71335-1797-1) | 30 tablet | 2021-12-20 | 0000-00-00 | No | No | Current |
| 71335-1797-2 | 71335179702 | 120 TABLET in 1 BOTTLE (71335-1797-2) | 120 tablet | 2021-12-20 | 0000-00-00 | No | No | Current |
| 71335-1797-3 | 71335179703 | 20 TABLET in 1 BOTTLE (71335-1797-3) | 20 tablet | 2021-12-20 | 0000-00-00 | No | No | Current |
| 71335-1797-4 | 71335179704 | 60 TABLET in 1 BOTTLE (71335-1797-4) | 60 tablet | 2021-12-20 | 0000-00-00 | No | No | Current |
| 71335-1797-5 | 71335179705 | 100 TABLET in 1 BOTTLE (71335-1797-5) | 100 tablet | 2021-12-20 | 0000-00-00 | No | No | Current |
| 71335-1797-6 | 71335179706 | 56 TABLET in 1 BOTTLE (71335-1797-6) | 56 tablet | 2021-12-20 | 0000-00-00 | No | No | Current |
| 71335-1797-7 | 71335179707 | 90 TABLET in 1 BOTTLE (71335-1797-7) | 90 tablet | 2021-12-20 | 0000-00-00 | No | No | Current |
| 71335-1797-8 | 71335179708 | 140 TABLET in 1 BOTTLE (71335-1797-8) | 140 tablet | 2021-12-20 | 0000-00-00 | No | No | Current |
| 71335-1797-9 | 71335179709 | 84 TABLET in 1 BOTTLE (71335-1797-9) | 84 tablet | 2021-12-20 | 0000-00-00 | No | No | Current |