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Active ingredient

Ipratropium

36 finished FDA listings contain Ipratropium as their only active ingredient; 18 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
IPRATROPIUM BROMIDE
Dosage forms
Aerosol, Aerosol, Metered, Solution, Spray, Spray, Metered
Routes
Nasal, Respiratory (Inhalation)
Manufacturers / labelers
24
Strengths listed
.5 mg/2.5ml · 17 ug/1 · 21 ug/1 · 42 ug/1
Brand names in FDA listings
Atrovent Hfa

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 7213

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 075693RITEDOSE CORP2001-01-269
ANDA 075562NEPHRON2001-09-273
ANDA 076103BAUSCH2003-03-312
ANDA 076025BAUSCH2003-03-312
ANDA 076156APOTEX INC2003-04-182
ANDA 076155APOTEX INC2003-04-183
ANDA 076598HIKMA2003-11-052
ANDA 076664HIKMA2003-11-052
NDA 021527BOEHRINGER INGELHEIM2004-11-171
ANDA 206543LUOXIN AUROVITAS2016-10-271
ANDA 207903SUN PHARM2017-01-031
ANDA 215104AMNEAL2022-08-161
ANDA 215105AMNEAL2022-08-161
ANDA 219221RUBICON RESEARCH2024-11-151
ANDA 219222RUBICON RESEARCH2025-01-141
ANDA 217886LUPIN2025-01-272
ANDA 217912LUPIN2025-02-071
ANDA 217953ARMSTRONG PHARMS2026-02-231

Official labeling on DailyMed

Showing the 12 most recent of 34 labels.

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