Drug
Who makes carbinoxamine maleate?
9 companies list carbinoxamine maleate as a human prescription drug, including under the names Karbinal ER, CARBZAH, RyVent. Forms: solution; suspension, extended release; tablet. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing carbinoxamine maleate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Genus Lifesciences Inc.United States | solution; tablet | ANDAANDA040442, ANDA040458 | 2 | 2 |
| Leading Pharma, LLCUnited States | tablet | ANDAANDA215476 | 1 | 1 |
| Aytu Therapeutics, LLC | suspension, extended release | NDANDA022556 | 1 | 0 |
| BioComp Pharma, Inc. | tablet | ANDAANDA090756 | 1 | 0 |
| BluCrest Pharmaceuticals, LLC | tablet | ANDAANDA207484 | 1 | 0 |
| Carwin Pharmaceutical Associates, LLC | tablet | ANDAANDA207484 | 1 | 0 |
| IPG Pharmaceuticals, Inc. | solution | ANDAANDA040458 | 1 | 0 |
| Neos Therapeutics, LP | suspension, extended release | NDA AUTHORIZED GENERICNDA022556 | 1 | 0 |
| TRIPOINT THERAPEUTICS, LLC | tablet | ANDAANDA215476 | 1 | 0 |
Bulk ingredient listings
- Kongo Chemical Co., Ltd.Japan · 1 NDC
- MSN Pharmachem Private LimitedIndia · 1 NDC
- R.L.Fine Chem Private LimitedIndia · 1 NDC
- Symed Labs Limited · 1 NDC
- Viyash Scientific LimitedIndia · 1 NDC
Orange Book patents
2 unexpired patents list carbinoxamine maleate as the active ingredient, expiring between Jun 2027 and Mar 2029. Application holder: AYTU BIOSCIENCE INC.
Enquiry
Common questions
- Who makes carbinoxamine maleate?
- 9 companies list carbinoxamine maleate as a human prescription drug in the openFDA NDC Directory, led by Genus Lifesciences Inc., Leading Pharma, LLC, Aytu Therapeutics, LLC, BioComp Pharma, Inc., BluCrest Pharmaceuticals, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Karbinal ER?
- 7 companies list carbinoxamine maleate under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies carbinoxamine maleate active ingredient?
- 5 companies list carbinoxamine maleate as a bulk ingredient, including Kongo Chemical Co., Ltd., MSN Pharmachem Private Limited, R.L.Fine Chem Private Limited, Symed Labs Limited.