Baclofen
- Product NDC
- 0615-8411
- 11-digit product format
- 006158411
- Labeler code
- 0615
- Product ID
- 0615-8411_09957659-c9d6-4c07-afaf-0776f750b94d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA077971
- Marketing category
- ANDA
- Marketing start
- 2007-10-26
- 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 |
|---|
| 0615-8411-05 | 00615841105 | 15 TABLET in 1 BLISTER PACK (0615-8411-05) | 15 tablet | 2021-11-02 | 0000-00-00 | No | No | Current |
| 0615-8411-39 | 00615841139 | 30 TABLET in 1 BLISTER PACK (0615-8411-39) | 30 tablet | 2021-11-02 | 0000-00-00 | No | No | Current |