Baclofen
- Product NDC
- 71335-1356
- 11-digit product format
- 713351356
- Labeler code
- 71335
- Product ID
- 71335-1356_018c5e52-baa0-4aff-a1ff-604cc1bf20a9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA211659
- Marketing category
- ANDA
- Marketing start
- 2018-12-06
- 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 | 197392 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1356 | BACLOFEN TABLET [BRYANT RANCH PREPACK] | 5 | Current NDC, Legacy NDC, 10 package rows | 20240915_5b92b0a6-ebba-4815-8b94-f2014674399b.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 |
|---|
| 71335-1356-0 | 71335135600 | 120 TABLET in 1 BOTTLE (71335-1356-0) | 120 tablet | 2020-03-17 | 0000-00-00 | No | No | Current |
| 71335-1356-1 | 71335135601 | 90 TABLET in 1 BOTTLE (71335-1356-1) | 90 tablet | 2019-11-13 | 0000-00-00 | No | No | Current |
| 71335-1356-2 | 71335135602 | 20 TABLET in 1 BOTTLE (71335-1356-2) | 20 tablet | 2024-09-05 | 0000-00-00 | No | No | Current |
| 71335-1356-3 | 71335135603 | 60 TABLET in 1 BOTTLE (71335-1356-3) | 60 tablet | 2019-12-06 | 0000-00-00 | No | No | Current |
| 71335-1356-4 | 71335135604 | 45 TABLET in 1 BOTTLE (71335-1356-4) | 45 tablet | 2024-09-05 | 0000-00-00 | No | No | Current |
| 71335-1356-5 | 71335135605 | 112 TABLET in 1 BOTTLE (71335-1356-5) | 112 tablet | 2024-09-05 | 0000-00-00 | No | No | Current |
| 71335-1356-6 | 71335135606 | 30 TABLET in 1 BOTTLE (71335-1356-6) | 30 tablet | 2020-04-20 | 0000-00-00 | No | No | Current |
| 71335-1356-7 | 71335135607 | 56 TABLET in 1 BOTTLE (71335-1356-7) | 56 tablet | 2024-09-05 | 0000-00-00 | No | No | Current |
| 71335-1356-8 | 71335135608 | 15 TABLET in 1 BOTTLE (71335-1356-8) | 15 tablet | 2024-09-05 | 0000-00-00 | No | No | Current |
| 71335-1356-9 | 71335135609 | 84 TABLET in 1 BOTTLE (71335-1356-9) | 84 tablet | 2024-09-05 | 0000-00-00 | No | No | Current |