OZOBAX
- Product NDC
- 69528-301
- 11-digit product format
- 695280301
- Labeler code
- 69528
- Product ID
- 69528-301_f113c7bd-3f54-3ec8-e053-2995a90abdb6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Metacel Pharmaceuticals, LLC
- Application
- NDA208193
- Marketing category
- NDA
- Marketing start
- 2019-09-18
- Marketing end
- 0000-00-00
- Substance
- BACLOFEN
- Active strength
- 5 mg/5mL
- Pharmacologic classes
- GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|
| 69528-301-16 | 69528030116 | 473 mL in 1 BOTTLE (69528-301-16) | 473 ml | 2019-09-18 | 0000-00-00 | No | No | Current |