Active ingredient
Clemastine
4 finished FDA listings contain Clemastine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CLEMASTINE FUMARATE
- Dosage forms
- Syrup, Tablet
- Routes
- Oral
- Manufacturers / labelers
- 3
- Strengths listed
- .67 mg/5ml · 2.68 mg/1
- Brand names in FDA listings
- Clemsza
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2578
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 073283 | GENUS | 1992-01-31 | 2 |
| ANDA 073399 | GENUS | 1994-06-30 | 1 |
| ANDA 074884 | GENUS LIFESCIENCES | 1997-12-17 | 1 |
Official labeling on DailyMed
- CLEMSZA (CLEMASTINE FUMARATE) TABLET [IPG PHARMACEUTICALS, INC.] · version 1 · 2025-08-04
- CLEMASTINE FUMARATE TABLET [GENUS LIFESCIENCES] · version 2 · 2025-02-06
- CLEMASTINE FUMARATE SYRUP [GENUS LIFESCIENCES] · version 1 · 2024-11-27
- CLEMASTINE FUMARATE SYRUP [CHARTWELL RX, LLC] · version 1 · 2023-07-10
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.