Active ingredient
Cefaclor
5 finished FDA listings contain Cefaclor as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CEFACLOR
- Dosage forms
- Capsule, Suspension, Tablet, Film Coated, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 4
- Strengths listed
- 250 mg/1 · 250 mg/5ml · 500 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2176
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 065058 | TEVA | 2002-09-04 | 1 |
| ANDA 065146 | YUNG SHIN PHARM | 2004-01-22 | 3 |
| ANDA 065412 | YUNG SHIN PHARM | 2012-02-17 | 1 |
Official labeling on DailyMed
- CEFACLOR CAPSULE [CARLSBAD TECHNOLOGY, INC.] · version 4 · 2025-05-05
- CEFACLOR CAPSULE [A-S MEDICATION SOLUTIONS] · version 10 · 2024-02-01
- CEFACLOR SUSPENSION [AZORIAN PHARMA, LLC] · version 1 · 2022-11-09
- CEFACLOR TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA, INC.] · version 11 · 2021-05-20
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.