Active ingredient
Clarithromycin
54 finished FDA listings contain Clarithromycin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CLARITHROMYCIN
- Dosage forms
- For Suspension, Tablet, Tablet, Film Coated, Tablet, Film Coated, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 26
- Strengths listed
- 125 mg/5ml · 250 mg/1 · 250 mg/5ml · 500 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 21212
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 065145 | ACTAVIS LABS FL INC | 2004-06-24 | 1 |
| ANDA 065136 | SANDOZ | 2005-08-25 | 9 |
| ANDA 065144 | SANDOZ | 2005-10-18 | 1 |
| ANDA 065384 | CHARTWELL | 2007-08-20 | 2 |
| ANDA 065283 | SANDOZ | 2007-09-04 | 3 |
| ANDA 065489 | AUROBINDO | 2012-07-25 | 21 |
| ANDA 203584 | HEC PHARM | 2015-09-28 | 7 |
| ANDA 208987 | SUNSHINE | 2018-07-09 | 4 |
| ANDA 210459 | ALEMBIC | 2022-01-31 | 6 |
Official labeling on DailyMed
- CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] · version 38 · 2026-08-06
- CLARITHROMYCIN TABLET, FILM COATED [REMEDYREPACK INC.] · version 14 · 2026-06-26
- CLARITHROMYCIN TABLET, FILM COATED [SPORTPHARM LLC] · version 1 · 2026-04-23
- CLARITHROMYCIN TABLET, FILM COATED [SOLARIS PHARMA CORPORATION] · version 2 · 2026-04-13
- CLARITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] · version 3 · 2026-04-06
- CLARITHROMYCIN TABLET, FILM COATED [NORTHWIND HEALTH COMPANY, LLC] · version 3 · 2026-04-03
- CLARITHROMYCIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS] · version 5 · 2026-04-02
- CLARITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] · version 4 · 2026-03-31
- CLARITHROMYCIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] · version 6 · 2026-03-20
- CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [SOLARIS PHARMA CORPORATION] · version 1 · 2026-03-19
- CLARITHROMYCIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] · version 2 · 2026-03-05
- CLARITHROMYCIN FOR SUSPENSION [A-S MEDICATION SOLUTIONS] · version 19 · 2026-02-20
Showing the 12 most recent of 41 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.