Active ingredient
Cefixime
12 finished FDA listings contain Cefixime as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CEFIXIME
- Dosage forms
- Capsule, Powder, For Suspension, Tablet
- Routes
- Oral
- Manufacturers / labelers
- 6
- Strengths listed
- 100 mg/5ml · 200 mg/5ml · 400 mg/1
- Brand names in FDA listings
- Cefixime 400 Mg
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 25033
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 065129 | LUPIN PHARMS | 2004-02-23 | 1 |
| ANDA 065355 | LUPIN PHARMS | 2007-04-10 | 1 |
| NDA 203195 | LUPIN LTD | 2012-06-01 | 2 |
| ANDA 204835 | AUROBINDO PHARMA LTD | 2015-04-14 | 2 |
| ANDA 210574 | ALKEM LABS LTD | 2018-10-09 | 3 |
| ANDA 206358 | FDC LTD | 2024-12-17 | 1 |
| ANDA 217607 | AUROBINDO PHARMA LTD | 2026-03-23 | 2 |
Official labeling on DailyMed
- CEFIXIME CAPSULE [REMEDYREPACK INC.] · version 10 · 2026-08-07
- CEFIXIME CAPSULE [REMEDYREPACK INC.] · version 14 · 2026-07-30
- CEFIXIME TABLET [RISING PHARMA HOLDINGS, INC.] · version 3 · 2026-04-13
- CEFIXIME CAPSULE [AUROBINDO PHARMA LIMITED] · version 1 · 2026-04-02
- CEFIXIME 400 MG (CEFIXIME) CAPSULE [HEALTH DEPARTMENT, OKLAHOMA STATE] · version 3 · 2026-01-01
- CEFIXIME POWDER, FOR SUSPENSION CEFIXIME CAPSULE [LUPIN PHARMACEUTICALS, INC.] · version 14 · 2025-11-17
- CEFIXIME POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] · version 9 · 2024-02-16
- CEFIXIME CAPSULE [ASCEND LABORATORIES, LLC] · version 10 · 2022-06-06
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.