Active ingredient
Quinidine
5 finished FDA listings contain Quinidine as their only active ingredient; 6 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- QUINIDINE GLUCONATE, QUINIDINE SULFATE
- Dosage forms
- Tablet, Tablet, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 4
- Strengths listed
- 200 mg/1 · 300 mg/1 · 324 mg/1
- Brand names in FDA listings
- Quinidine Gluconate, Quinidine Sulfate
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 9068
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 088072 | EPIC PHARMA LLC | 1983-09-26 | 2 |
| ANDA 089338 | SUN PHARM INDUSTRIES | 1987-02-11 | 2 |
| ANDA 212589 | ADAPTIS | 2021-09-17 | 1 |
Official labeling on DailyMed
- QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY] · version 2 · 2024-08-29
- QUINIDINE SULFATE (QUINIDINE SULFATE TABLET) TABLET [EPIC PHARMA, LLC] · version 2 · 2023-12-21
- QUINIDINE GLUCONATE (QUINIDINE GLUONATE) TABLET, EXTENDED RELEASE [EYWA PHARMA INC] · version 2 · 2022-03-21
- QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 5 · 2018-02-27
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.