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FDA Approval

Ketorolac Tromethamine

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

FDA Approval Summary

Company
Sagent Pharmaceuticals
DUNS: 080579617
Effective Date
June 20, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ketorolac(30 mg in 1 mL)

Products2

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
25021-701
Application Number
ANDA204216
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, INTRAMUSCULAR
Effective Date
June 20, 2023
KetorolacActive
Code: 4EVE5946BQClass: ACTIBQuantity: 30 mg in 1 mL
alcoholInactive
Code: 3K9958V90MClass: IACT
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
hydrochloric acidInactive
Code: QTT17582CBClass: IACT

Ketorolac Tromethamine

Product Details

NDC Product Code
25021-700
Application Number
ANDA204216
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, INTRAMUSCULAR
Effective Date
June 20, 2023
alcoholInactive
Code: 3K9958V90MClass: IACT
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
KetorolacActive
Code: 4EVE5946BQClass: ACTIBQuantity: 15 mg in 1 mL
waterInactive
Code: 059QF0KO0RClass: IACT
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
hydrochloric acidInactive
Code: QTT17582CBClass: IACT
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