Ketorolac Tromethamine
Ketorolac Tromethamine Injection, USP
Approved
Approval ID
3b3ed392-c37b-4fbc-bf30-e6400a201acb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2019
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ketorolac tromethamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71205-116
Application NumberANDA204216
Product Classification
M
Marketing Category
C73584
G
Generic Name
ketorolac tromethamine
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateDecember 1, 2018
FDA Product Classification
INGREDIENTS (6)
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
ketorolac tromethamineActive
Quantity: 30 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIB
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT