Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Hospira, Inc.
Hospira, Inc.
827731089
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ketorolac Tromethamine
Product Details
NDC Product Code
0409-3793Application Number
ANDA074802Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAR, INTRAVENOUSEffective Date
January 4, 2023KetorolacActive
Code: 4EVE5946BQClass: ACTIBQuantity: 15 mg in 1 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 6.68 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Ketorolac Tromethamine
Product Details
NDC Product Code
0409-3796Application Number
ANDA074802Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAREffective Date
January 4, 2023KetorolacActive
Code: 4EVE5946BQClass: ACTIBQuantity: 60 mg in 2 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8.7 mg in 2 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
Ketorolac Tromethamine
Product Details
NDC Product Code
0409-3795Application Number
ANDA074802Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAR, INTRAVENOUSEffective Date
January 4, 2023KetorolacActive
Code: 4EVE5946BQClass: ACTIBQuantity: 30 mg in 1 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 4.35 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT