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Active ingredient

Hydromorphone

74 finished FDA listings contain Hydromorphone as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
HYDROMORPHONE HYDROCHLORIDE
Dosage forms
Injection, Injection, Solution, Solution, Suppository, Tablet, Tablet, Extended Release
Routes
Intramuscular, Intravenous, Oral, Rectal, Subcutaneous
Manufacturers / labelers
17
Strengths listed
.2 mg/ml · .25 mg/.5ml · .5 mg/.5ml · 1 mg/ml · 10 mg/ml · 12 mg/1 · 16 mg/1 · 2 mg/1 · 2 mg/ml · 3 mg/1 · 32 mg/1 · 4 mg/1 · 4 mg/ml · 5 mg/5ml · 8 mg/1
Brand names in FDA listings
Dilaudid

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 3423

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 019034FRESENIUS KABI USA1984-01-117
NDA 019892RHODES PHARMS1992-12-0712
NDA 019891RHODES PHARMS1992-12-073
ANDA 074653HIKMA1998-07-291
ANDA 076855SPECGX LLC2004-12-236
ANDA 078591HOSPIRA INC2008-06-174
NDA 200403HOSPIRA INC2011-12-018
ANDA 204278PADAGIS US2015-04-064
ANDA 205814AUROLIFE PHARMA LLC2016-05-134
ANDA 205629OSMOTICA PHARM US2016-07-074
ANDA 210176ASCENT PHARMS INC2017-10-271
ANDA 210506ASCENT PHARMS INC2018-01-173
ANDA 202159HIKMA2018-04-271
ANDA 212133ASCENT PHARMS INC2020-09-238
NDA 217812HIKMA2023-12-141
ANDA 216899HIKMA2024-02-094

Official labeling on DailyMed

Showing the 12 most recent of 31 labels.

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