Active ingredient
Cefdinir
78 finished FDA listings contain Cefdinir as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CEFDINIR, CEFDINIR MONOHYDRATE
- Dosage forms
- Capsule, Powder, For Suspension
- Routes
- Oral
- Manufacturers / labelers
- 25
- Strengths listed
- 125 mg/5ml · 250 mg/5ml · 300 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 25037
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 065264 | LUPIN | 2006-05-19 | 4 |
| ANDA 065259 | LUPIN | 2006-05-31 | 12 |
| ANDA 065330 | CHARTWELL RX | 2007-04-06 | 2 |
| ANDA 065332 | TEVA PHARMS | 2007-05-04 | 7 |
| ANDA 065368 | TEVA PHARMS | 2007-05-09 | 2 |
| ANDA 065473 | AUROBINDO PHARMA | 2007-12-14 | 12 |
| ANDA 065434 | AUROBINDO PHARMA | 2008-01-07 | 18 |
| ANDA 210534 | ALKEM LABS LTD | 2021-02-19 | 6 |
| ANDA 210220 | ALKEM LABS LTD | 2021-02-19 | 15 |
Official labeling on DailyMed
- CEFDINIR POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS, INC.] · version 1 · 2026-09-02
- CEFDINIR CAPSULE [REMEDYREPACK INC.] · version 6 · 2026-08-31
- CEFDINIR POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS] · version 6 · 2026-08-21
- CEFDINIR CAPSULE [NORTHWIND HEALTH COMPANY, LLC] · version 3 · 2026-07-13
- CEFDINIR CAPSULE [PROFICIENT RX LP] · version 3 · 2026-06-26
- CEFDINIR CAPSULE [NUCARE PHARMACEUTICALS, INC.] · version 1 · 2026-05-11
- CEFDINIR POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.] · version 1 · 2026-04-24
- CEFDINIR POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.] · version 6 · 2026-03-26
- CEFDINIR CAPSULE [PREFERRED PHARMACEUTICALS, INC.] · version 4 · 2026-03-26
- CEFDINIR POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.] · version 7 · 2026-03-26
- CEFDINIR CAPSULE [PREFERRED PHARMACEUTICALS INC.] · version 4 · 2026-03-26
- CEFDINIR POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.] · version 3 · 2026-03-26
Showing the 12 most recent of 70 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.