Active ingredient
Methscopolamine
10 finished FDA listings contain Methscopolamine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- METHSCOPOLAMINE BROMIDE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 5
- Strengths listed
- 2.5 mg/1 · 5 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 89785
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 040642 | BRECKENRIDGE PHARM | 2011-12-06 | 2 |
| ANDA 200602 | UNICHEM | 2012-09-24 | 6 |
| ANDA 216786 | NE RX PHARMA | 2024-02-01 | 2 |
Official labeling on DailyMed
- METHSCOPOLAMINE BROMIDE TABLET [BRYANT RANCH PREPACK] · version 102 · 2026-07-01
- METHSCOPOLAMINE BROMIDE TABLET [BRYANT RANCH PREPACK] · version 101 · 2026-03-18
- METHSCOPOLAMINE BROMIDE TABLET [PD-RX PHARMACEUTICALS, INC.] · version 11 · 2026-01-06
- METHSCOPOLAMINE BROMIDE TABLET [PD-RX PHARMACEUTICALS, INC.] · version 11 · 2026-01-06
- METHSCOPOLAMINE BROMIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] · version 9 · 2025-12-12
- METHSCOPOLAMINE BROMIDE TABLET [I3 PHARMACEUTICALS, LLC] · version 3 · 2025-02-27
- METHSCOPOLAMINE BROMIDE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] · version 6 · 2024-03-27
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.