BACLOFEN
- Product NDC
- 70934-918
- 11-digit product format
- 709340918
- Labeler code
- 70934
- Product ID
- 70934-918_f06e527b-159e-29d9-e053-2a95a90aab35
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BACLOFEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Denton Pharma, Inc. DBA Northwind Pharmaceuticals
- Application
- ANDA209102
- Marketing category
- ANDA
- Marketing start
- 2021-11-04
- Marketing end
- 2024-05-31
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70934-918-30 | 70934091830 | 30 TABLET in 1 BOTTLE, PLASTIC (70934-918-30) | 30 tablet | 2021-11-04 | 0000-00-00 | No | No | Current |
| 70934-918-60 | 70934091860 | 60 TABLET in 1 BOTTLE, PLASTIC (70934-918-60) | 60 tablet | 2022-03-18 | 0000-00-00 | No | No | Current |