Baclofen
- Product NDC
- 71335-0103
- 11-digit product format
- 713350103
- Labeler code
- 71335
- Product ID
- 71335-0103_60ded7d2-5758-4bcb-9aec-928a434f3efc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA077241
- Marketing category
- ANDA
- Marketing start
- 2005-12-20
- 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#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-0103 | BACLOFEN TABLET [BRYANT RANCH PREPACK] | 11 | Current NDC, Legacy NDC, 10 package rows | 20250125_58816b46-28a5-48e2-b89d-98df65939386.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 |
|---|
| 71335-0103-0 | 71335010300 | 120 TABLET in 1 BOTTLE (71335-0103-0) | 120 tablet | 2018-03-06 | 0000-00-00 | No | No | Current |
| 71335-0103-1 | 71335010301 | 90 TABLET in 1 BOTTLE (71335-0103-1) | 90 tablet | 2018-02-15 | 0000-00-00 | No | No | Current |
| 71335-0103-2 | 71335010302 | 20 TABLET in 1 BOTTLE (71335-0103-2) | 20 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0103-3 | 71335010303 | 60 TABLET in 1 BOTTLE (71335-0103-3) | 60 tablet | 2018-02-12 | 0000-00-00 | No | No | Current |
| 71335-0103-4 | 71335010304 | 45 TABLET in 1 BOTTLE (71335-0103-4) | 45 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0103-5 | 71335010305 | 112 TABLET in 1 BOTTLE (71335-0103-5) | 112 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0103-6 | 71335010306 | 30 TABLET in 1 BOTTLE (71335-0103-6) | 30 tablet | 2018-02-26 | 0000-00-00 | No | No | Current |
| 71335-0103-7 | 71335010307 | 56 TABLET in 1 BOTTLE (71335-0103-7) | 56 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0103-8 | 71335010308 | 15 TABLET in 1 BOTTLE (71335-0103-8) | 15 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |
| 71335-0103-9 | 71335010309 | 84 TABLET in 1 BOTTLE (71335-0103-9) | 84 tablet | 2021-12-27 | 0000-00-00 | No | No | Current |