# Baclofen by Acella Pharmaceuticals, LLC: new human prescription drug listing

**Launch Signal Score:** 70/100

| Field | Value |
|---|---|
| Product | Baclofen |
| Generic name | Baclofen |
| NDC | 42192-631 |
| Labeler | Acella Pharmaceuticals, LLC |
| Product type | HUMAN PRESCRIPTION DRUG |
| Approval pathway | NDA |
| Application number | NDA208193 |
| Dosage form | SOLUTION |
| Route | ORAL |
| Active ingredients | BACLOFEN 10 mg/5mL |
| Marketing start | 2026-10-26 |
| Package configurations | 2 |

## Why this score
- Prescription or biologic product.
- Brand or biologic launch.

Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=42192-631). Last refreshed: 2026-11-04T18:12:05.743Z.
Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.