baclofen
- Product NDC
- 67457-563
- 11-digit product format
- 674570563
- Labeler code
- 67457
- Product ID
- 67457-563_c55c7232-a964-4d6d-bb4e-8c0f1843a7fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- baclofen
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRATHECAL
- Labeler
- Mylan Institutional LLC
- Application
- ANDA209594
- Marketing category
- ANDA
- Marketing start
- 2018-12-21
- Marketing end
- 0000-00-00
- Substance
- BACLOFEN
- Active strength
- 1000 ug/mL
- Pharmacologic classes
- GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67457-563-20 | 67457056320 | 1 VIAL, GLASS in 1 CARTON (67457-563-20) > 20 mL in 1 VIAL, GLASS | 2018-12-21 | 0000-00-00 | No | No | Current |