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Active ingredient

Amlodipine

197 finished FDA listings contain Amlodipine as their only active ingredient; 358 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
AMLODIPINE, AMLODIPINE BENZOATE, AMLODIPINE BESYLATE
Dosage forms
Solution, Suspension, Tablet
Routes
Oral
Manufacturers / labelers
48
Strengths listed
1 mg/ml · 10 mg/1 · 2.5 mg/1 · 5 mg/1 · 5 mg/5mg
Brand names in FDA listings
Amlodipine Besylate 10 Mg, Amlodipine Besylate 2.5 Mg, Amlodipine Besylate 5 Mg, Katerzia, Norliqva, Norvasc, Sdamlo

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 17767

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
NDA 019787VIATRIS1992-07-3110
ANDA 076719COREPHARMA2007-05-238
ANDA 076846TEVA2007-06-289
ANDA 078226ZYDUS PHARMS USA2007-07-0915
ANDA 078043LUPIN2007-07-1211
ANDA 078021AUROBINDO PHARMA2007-07-173
ANDA 077955INVAGEN PHARMS2007-08-2814
ANDA 077073CIPLA2007-09-2617
ANDA 078552EPIC PHARMA LLC2009-04-086
ANDA 078925ALKEM2009-05-0453
ANDA 078414OXFORD PHARMS2010-04-0716
ANDA 090752CHINA RESOURCES2011-04-153
ANDA 203245UNICHEM2013-10-2125
ANDA 206367INVAGEN PHARMS2015-12-103
NDA 211340AZURITY2019-07-081
NDA 214439CMP DEV LLC2022-02-242
NDA 219531BRILLIAN PHARMA2025-07-241

Official labeling on DailyMed

Showing the 12 most recent of 129 labels.

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