Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Proficient Rx LP
Proficient Rx LP
079196022
Products1
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
71205-116Application Number
ANDA204216Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, INTRAMUSCULAREffective Date
December 1, 2018sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
KetorolacActive
Code: 4EVE5946BQClass: ACTIBQuantity: 30 mg in 1 mL
hydrochloric acidInactive
Code: QTT17582CBClass: IACT
alcoholInactive
Code: 3K9958V90MClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT