Baclofen
- Product NDC
- 0615-3542
- 11-digit product format
- 006153542
- Labeler code
- 0615
- Product ID
- 0615-3542_2ed52df2-0435-4344-8754-0d4c53e88f7d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA072235
- Marketing category
- ANDA
- Marketing start
- 2010-07-15
- Marketing end
- 2023-07-31
- 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
- 0000-00-00
- 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 |
|---|
| 0615-3542-39 | 00615354239 | 30 TABLET in 1 BLISTER PACK (0615-3542-39) | 30 tablet | 2010-07-15 | 2023-07-31 | No | No | Current |