Baclofen
- Product NDC
- 71610-391
- 11-digit product format
- 716100391
- Labeler code
- 71610
- Product ID
- 71610-391_9426da49-2adb-4bda-b1e8-6122a1886bba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA077068
- Marketing category
- ANDA
- Marketing start
- 2005-08-30
- 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
- 2021-12-31
- 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 |
|---|
| 71610-391-45 | 71610039145 | 45 TABLET in 1 BOTTLE, PLASTIC (71610-391-45) | 45 tablet | 2020-01-24 | 0000-00-00 | No | No | Current |
| 71610-391-60 | 71610039160 | 90 TABLET in 1 BOTTLE, PLASTIC (71610-391-60) | 90 tablet | 2020-01-24 | 0000-00-00 | No | No | Current |
| 71610-391-92 | 71610039192 | 270 TABLET in 1 BOTTLE, PLASTIC (71610-391-92) | 270 tablet | 2020-01-24 | 0000-00-00 | No | No | Current |