Baclofen
- Product NDC
- 68788-7915
- 11-digit product format
- 687887915
- Labeler code
- 68788
- Product ID
- 68788-7915_c9fa6eb8-2131-4c8d-8461-8c030d70e165
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA212378
- Marketing category
- ANDA
- Marketing start
- 2021-05-27
- 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-7915-1 | 68788791501 | 100 TABLET in 1 BOTTLE (68788-7915-1) | 100 tablet | 2021-05-27 | 0000-00-00 | No | No | Current |
| 68788-7915-3 | 68788791503 | 30 TABLET in 1 BOTTLE (68788-7915-3) | 30 tablet | 2021-05-27 | 0000-00-00 | No | No | Current |
| 68788-7915-6 | 68788791506 | 60 TABLET in 1 BOTTLE (68788-7915-6) | 60 tablet | 2021-05-27 | 0000-00-00 | No | No | Current |
| 68788-7915-8 | 68788791508 | 120 TABLET in 1 BOTTLE (68788-7915-8) | 120 tablet | 2021-05-27 | 0000-00-00 | No | No | Current |
| 68788-7915-9 | 68788791509 | 90 TABLET in 1 BOTTLE (68788-7915-9) | 90 tablet | 2021-05-27 | 0000-00-00 | No | No | Current |