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Active ingredient

Amoxicillin

273 finished FDA listings contain Amoxicillin as their only active ingredient; 207 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
AMOXICILLIN, AMOXICILLIN SODIUM
Dosage forms
Capsule, For Suspension, Powder, For Suspension, Tablet, Chewable, Tablet, Coated, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
39
Strengths listed
125 mg/1 · 125 mg/5ml · 200 mg/5ml · 250 mg/1 · 250 mg/5ml · 400 mg/5ml · 500 mg/1 · 875 mg/1
Brand names in FDA listings
Amoxicillin 500 Mg, Amoxil

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 723

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 061926CHARTWELL RX1976-02-098
ANDA 062058CHARTWELL1978-08-034
ANDA 062059CHARTWELL RX1978-12-082
ANDA 062216US ANTIBIOTICS1979-08-026
ANDA 061931CHARTWELL RX1982-12-017
ANDA 064013CHARTWELL RX1992-12-2212
ANDA 064076SANDOZ1994-09-3019
NDA 050760US ANTIBIOTICS1999-04-154
ANDA 065056CHARTWELL RX2000-09-185
ANDA 065119CHARTWELL RX2002-12-047
ANDA 065228SANDOZ2005-07-135
ANDA 065256AUROBINDO2005-11-0930
ANDA 065271AUROBINDO2005-11-0969
ANDA 065255HIKMA2006-03-2910
ANDA 065322HIKMA2006-06-1917
ANDA 065325HIKMA2006-06-1912
ANDA 065334AUROBINDO2006-12-2816
ANDA 065291HIKMA PHARMS2007-02-059
ANDA 065378SANDOZ2007-03-268
ANDA 065387SANDOZ2007-03-2611
ANDA 065319CHARTWELL RX2007-06-181
ANDA 204030AUROBINDO PHARMA LTD2014-09-159
ANDA 207471MICRO LABS2022-06-242

Official labeling on DailyMed

Showing the 12 most recent of 218 labels.

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