Lioresal (baclofen)
- Product NDC
- 70257-563
- 11-digit product format
- 702570563
- Labeler code
- 70257
- Product ID
- 70257-563_7280e190-0f51-11ed-aa05-0800200c9a66
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- baclofen
- Dosage form
- INJECTION
- Route
- INTRATHECAL
- Labeler
- Saol Therapeutics Inc.
- Application
- NDA020075
- Marketing category
- NDA
- Marketing start
- 2022-06-12
- Marketing end
- 2024-11-30
- Substance
- BACLOFEN
- Active strength
- 40 mg/20mL
- 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 |
|---|
| 70257-563-01 | 70257056301 | 1 AMPULE in 1 BOX (70257-563-01) > 20 mL in 1 AMPULE (70257-563-20) | 1 ampule | 2022-01-03 | 0000-00-00 | No | No | Current |
| 70257-563-02 | 70257056302 | 2 AMPULE in 1 BOX (70257-563-02) > 20 mL in 1 AMPULE (70257-563-20) | 2 ampule | 2022-01-03 | 0000-00-00 | No | No | Current |