Baclofen
- Product NDC
- 68788-7643
- 11-digit product format
- 687887643
- Labeler code
- 68788
- Product ID
- 68788-7643_131455f4-e319-4c43-bf65-d6538aa98eb1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA211555
- Marketing category
- ANDA
- Marketing start
- 2020-02-28
- Marketing end
- 0000-00-00
- 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
- 2022-12-31
- 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 |
|---|
| 68788-7643-1 | 68788764301 | 100 TABLET in 1 BOTTLE (68788-7643-1) | 100 tablet | 2020-02-28 | 0000-00-00 | No | No | Current |
| 68788-7643-3 | 68788764303 | 30 TABLET in 1 BOTTLE (68788-7643-3) | 30 tablet | 2020-02-28 | 0000-00-00 | No | No | Current |
| 68788-7643-6 | 68788764306 | 60 TABLET in 1 BOTTLE (68788-7643-6) | 60 tablet | 2020-02-28 | 0000-00-00 | No | No | Current |
| 68788-7643-8 | 68788764308 | 120 TABLET in 1 BOTTLE (68788-7643-8) | 120 tablet | 2020-02-28 | 0000-00-00 | No | No | Current |
| 68788-7643-9 | 68788764309 | 90 TABLET in 1 BOTTLE (68788-7643-9) | 90 tablet | 2020-02-28 | 0000-00-00 | No | No | Current |