Baclofen
- Product NDC
- 0115-1012
- 11-digit product format
- 001151012
- Labeler code
- 0115
- Product ID
- 0115-1012_c9f07c77-925d-41ba-b5e8-d6e8665ef27c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA077971
- Marketing category
- ANDA
- Marketing start
- 2007-10-27
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-1012 | BACLOFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 8 | Legacy NDC | 20231231_198a9d33-25de-4509-9f7d-166ce0c53a0c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0115-1012-01 | 00115101201 | 100 TABLET in 1 BOTTLE (0115-1012-01) | 100 tablet | 2007-10-27 | 0000-00-00 | No | No | Current |
| 0115-1012-02 | 00115101202 | 500 TABLET in 1 BOTTLE (0115-1012-02) | 500 tablet | 2007-10-27 | 0000-00-00 | No | No | Current |
| 0115-1012-03 | 00115101203 | 1000 TABLET in 1 BOTTLE (0115-1012-03) | 1000 tablet | 2007-10-27 | 0000-00-00 | No | No | Current |
| 0115-1012-08 | 00115101208 | 30 TABLET in 1 BOTTLE (0115-1012-08) | 30 tablet | 2007-10-27 | 0000-00-00 | No | No | Current |