Active ingredient
Carbinoxamine
10 finished FDA listings contain Carbinoxamine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CARBINOXAMINE MALEATE
- Dosage forms
- Solution, Suspension, Extended Release, Tablet
- Routes
- Oral
- Manufacturers / labelers
- 9
- Strengths listed
- 4 mg/1 · 4 mg/5ml · 6 mg/1
- Brand names in FDA listings
- Carbinoxamine Maleate Extended-Release Oral Suspension, Carbzah, Karbinal Er, Ryvent
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 20220
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 040442 | GENUS LIFESCIENCES | 2003-03-19 | 1 |
| ANDA 040458 | GENUS | 2003-04-25 | 2 |
| ANDA 090756 | MISSION PHARMACAL | 2011-05-27 | 1 |
| NDA 022556 | AYTU | 2013-03-28 | 2 |
| ANDA 207484 | PHARMOBEDIENT | 2016-05-31 | 2 |
| ANDA 215476 | LEADING | 2024-12-19 | 2 |
Official labeling on DailyMed
- CARBINOXAMINE MALEATE EXTENDED-RELEASE ORAL SUSPENSION (CARBINOXAMINE MALEATE) SUSPENSION, EXTENDED RELEASE [NEOS THERAPEUTICS, LP] · version 4 · 2026-04-08
- KARBINAL ER (CARBINOXAMINE MALEATE) SUSPENSION, EXTENDED RELEASE [AYTU THERAPEUTICS, LLC] · version 15 · 2026-03-18
- CARBINOXAMINE MALEATE TABLET [BLUCREST PHARMACEUTICALS, LLC] · version 2 · 2026-01-08
- CARBINOXAMINE MALEATE TABLET [BIOCOMP PHARMA, INC.] · version 8 · 2025-12-19
- CARBINOXAMINE MALEATE TABLET [TRIPOINT THERAPEUTICS, LLC] · version 2 · 2025-08-11
- CARBINOXAMINE MALEATE TABLET [LEADING PHARMA, LLC] · version 3 · 2025-08-04
- CARBZAH (CARBINOXAMINE MALEATE) SOLUTION [IPG PHARMACEUTICALS, INC.] · version 3 · 2025-06-18
- CARBINOXAMINE MALEATE SOLUTION CARBINOXAMINE MALEATE TABLET [GENUS LIFESCIENCES INC.] · version 6 · 2024-03-15
- RYVENT (CARBINOXAMINE MALEATE) TABLET [CARWIN PHARMACEUTICAL ASSOCIATES, LLC] · version 4 · 2024-01-10
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.