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Active ingredient

Ketorolac

188 finished FDA listings contain Ketorolac as their only active ingredient; 2 combination products also contain it.

FDA NDC Directory

Ingredient names as written by FDA
KETOROLAC, KETOROLAC TROMETHAMINE
Dosage forms
Injection, Injection, Solution, Solution, Solution/ Drops, Spray, Metered, Tablet, Tablet, Film Coated
Routes
Intramuscular, Intravenous, Nasal, Ophthalmic, Oral
Manufacturers / labelers
63
Strengths listed
10 mg/1 · 15 mg/ml · 15.75 mg/1 · 30 mg/ml · 4 mg/ml · 4.5 mg/ml · 5 mg/ml · 60 mg/2ml
Brand names in FDA listings
Acular, Acular Ls, Acuvail, Sprix, Toronova Ii Suik, Toronova Suik

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 35827

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 019700ABBVIE1992-11-091
ANDA 074761MYLAN1997-05-161
ANDA 074754TEVA1997-05-1613
ANDA 074802HOSPIRA1997-06-059
ANDA 075784FRESENIUS KABI USA2002-01-1112
NDA 021528ABBVIE2003-05-303
ANDA 075772HIKMA2004-07-213
ANDA 078299ONESOURCE SPECIALTY2007-07-163
ANDA 078737SUN PHARM2008-10-063
NDA 022427ABBVIE2009-07-221
ANDA 076583SANDOZ2009-11-054
ANDA 078434CHARTWELL RX2009-11-052
ANDA 076109APOTEX2009-11-053
ANDA 090017SUN PHARM2009-11-053
NDA 022382COSETTE2010-05-141
ANDA 201155ONESOURCE SPECIALTY2014-08-043
ANDA 203242FRESENIUS KABI USA2015-10-074
ANDA 204216GLAND2016-11-0126
ANDA 209900BAXTER HLTHCARE CORP2017-09-154
ANDA 210616CHARTWELL RX2018-08-161
ANDA 205191EUGIA PHARMA2018-11-151
ANDA 203410MICRO LABS LTD INDIA2019-04-054
ANDA 211445NEPHRON2020-08-201
ANDA 212939EUGIA PHARMA2020-10-203
ANDA 205190EUGIA PHARMA2020-12-031
ANDA 215788SENORES PHARMS2022-03-2314
ANDA 216651HETERO LABS LTD III2022-08-255
ANDA 217038ZYDUS LIFESCIENCES2022-10-219
ANDA 216407ATNAHS PHARMA US2022-10-211
ANDA 214456ALEMBIC2022-11-0211
ANDA 216759BIONPHARMA2023-02-239
ANDA 215745LEADING2023-02-232
ANDA 217789CAPLIN2023-05-1011
ANDA 217166ASPIRO2023-06-203
ANDA 218204CAPLIN2024-03-269

Official labeling on DailyMed

Showing the 12 most recent of 145 labels.

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