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Active ingredient

Morphine

155 finished FDA listings contain Morphine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
MORPHINE, MORPHINE SULFATE
Dosage forms
Capsule, Extended Release, Injection, Injection, Solution, Solution, Suppository, Tablet, Tablet, Extended Release, Tablet, Film Coated, Extended Release, Tincture
Routes
Epidural, Intramuscular, Intrathecal, Intravenous, Oral, Rectal
Manufacturers / labelers
30
Strengths listed
.5 mg/ml · 1 g/100ml · 1 mg/.5ml · 1 mg/30ml · 1 mg/ml · 10 g/1000ml · 10 mg/1 · 10 mg/5ml · 10 mg/ml · 100 mg/1 · 100 mg/5ml · 120 mg/1 · 15 mg/1 · 2 mg/ml · 20 mg/1 · 20 mg/5ml · 20 mg/ml · 200 mg/1 · 200 mg/20ml · 25 mg/ml · 30 mg/1 · 4 mg/ml · 40 mg/1 · 45 mg/1 · 5 mg/1 · 5 mg/ml · 50 mg/1 · 50 mg/ml · 500 mg/20ml · 60 mg/1 · 75 mg/1 · 8 mg/ml · 80 mg/1 · 90 mg/1
Brand names in FDA listings
Duramorph, Infumorph 200, Infumorph 500, Mitigo, Morphine Sulfate Er, Morphine Sulfate Extended Release, Ms Contin, Opium, Opium Tincture Deodorized

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 7052

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 018565HIKMA1984-09-184
NDA 019516KNOA PHARMA1987-05-293
ANDA 073510HOSPIRA1992-09-301
ANDA 073509HOSPIRA1992-09-301
ANDA 074769RHODES PHARMS1998-07-025
ANDA 074862RHODES PHARMS1998-07-0710
ANDA 076438SPECGX LLC2003-07-032
ANDA 076412SPECGX LLC2003-07-313
NDA 022207HIKMA2008-03-172
NDA 022195HIKMA2008-03-1711
ANDA 202348SPECGX LLC2011-07-151
NDA 202515HOSPIRA INC2011-11-145
ANDA 078761SUN PHARM INDS LTD2012-05-1118
ANDA 079040ACTAVIS ELIZABETH2013-01-166
ANDA 202104UPSHER SMITH LABS2013-06-037
NDA 204223FRESENIUS KABI USA2013-10-3011
ANDA 203518TRIS PHARMA INC2015-05-129
ANDA 205758HIKMA2015-05-214
ANDA 203602NOVEL LABS INC2015-12-165
ANDA 200411IMPAX LABS INC2016-04-127
ANDA 206573PHARM ASSOC2016-11-142
ANDA 204393PIRAMAL CRITICAL2018-07-162
ANDA 210610UPSHER SMITH LABS2019-07-222
ANDA 212451ALKEM LABS LTD2020-12-036
ANDA 211454WINDER LABS LLC2021-02-123
ANDA 202861INTL MEDICATION SYS2021-04-291
ANDA 203158ANDA REPOSITORY2021-08-046
ANDA 211452HIKMA2023-01-122
ANDA 215194SPECGX LLC2023-08-214

Official labeling on DailyMed

Showing the 12 most recent of 77 labels.

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