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Active ingredient

Cephalexin

186 finished FDA listings contain Cephalexin as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
CEPHALEXIN
Dosage forms
Capsule, For Suspension, Powder, For Suspension, Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
37
Strengths listed
125 mg/5ml · 250 mg/1 · 250 mg/5ml · 333 mg/1 · 500 mg/1 · 750 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 2231

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.

ApplicationSponsorOriginal approvalListings
ANDA 062703TEVA1987-02-134
ANDA 062702TEVA1987-02-1317
ANDA 062713AJENAT PHARMS1988-07-152
ANDA 063024TEVA1989-01-122
ANDA 065152CHARTWELL RX2005-02-242
ANDA 065234LUPIN2005-08-177
ANDA 065253AUROBINDO PHARMA2005-11-1631
ANDA 065229LUPIN2005-11-2517
ANDA 065336YUNG SHIN PHARM2007-07-252
ANDA 090836ALKEM LABS LTD2010-12-2075
ANDA 210221ALKEM LABS LTD2019-03-2621
ANDA 218817AUROBINDO PHARMA LTD2024-09-272
ANDA 218947ALKEM LABS LTD2024-09-272
ANDA 213568AUROBINDO PHARMA2026-06-092

Official labeling on DailyMed

Showing the 12 most recent of 152 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.