Baclofen
- Product NDC
- 68788-8181
- 11-digit product format
- 687888181
- Labeler code
- 68788
- Product ID
- 68788-8181_b9ac6187-5ae2-4785-98e0-c8d51846d074
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA212378
- Marketing category
- ANDA
- Marketing start
- 2022-04-28
- 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
- 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 |
|---|
| 68788-8181-1 | 68788818101 | 100 TABLET in 1 BOTTLE (68788-8181-1) | 100 tablet | 2022-04-28 | 0000-00-00 | No | No | Current |
| 68788-8181-3 | 68788818103 | 30 TABLET in 1 BOTTLE (68788-8181-3) | 30 tablet | 2022-04-28 | 0000-00-00 | No | No | Current |
| 68788-8181-6 | 68788818106 | 60 TABLET in 1 BOTTLE (68788-8181-6) | 60 tablet | 2022-04-28 | 0000-00-00 | No | No | Current |
| 68788-8181-8 | 68788818108 | 120 TABLET in 1 BOTTLE (68788-8181-8) | 120 tablet | 2022-04-28 | 0000-00-00 | No | No | Current |
| 68788-8181-9 | 68788818109 | 90 TABLET in 1 BOTTLE (68788-8181-9) | 90 tablet | 2022-04-28 | 0000-00-00 | No | No | Current |