KETOROLAC TROMETHAMINE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 012430880

Effective Date

September 20, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Ketorolac(15 mg in 1 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

0404-9952

Application Number

ANDA204216

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS, INTRAMUSCULAR

Effective Date

September 20, 2023

Ingredients

Code: 4EVE5946BQClass: ACTIBQuantity: 15 mg in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT