KETOROLAC TROMETHAMINE
Ketorolac Tromethamine Injection, USP FOR INTRAVENOUS/INTRAMUSCULAR USE (15 mg and 30 mg) FOR INTRAMUSCULAR USE ONLY (60 mg) Rx only
Approved
Approval ID
478aff0b-29fd-43b2-a701-5236b8f8e3df
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 4, 2023
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
Products 3
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 Code31722-305
Application NumberANDA217166
Product Classification
M
Marketing Category
C73584
G
Generic Name
KETOROLAC TROMETHAMINE
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateJuly 4, 2023
FDA Product Classification
INGREDIENTS (7)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 6.68 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
KETOROLAC TROMETHAMINEActive
Quantity: 15 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIB
KETOROLAC TROMETHAMINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-306
Application NumberANDA217166
Product Classification
M
Marketing Category
C73584
G
Generic Name
KETOROLAC TROMETHAMINE
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateJuly 4, 2023
FDA Product Classification
INGREDIENTS (7)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 6.68 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
KETOROLAC TROMETHAMINEActive
Quantity: 30 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIB
KETOROLAC TROMETHAMINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-307
Application NumberANDA217166
Product Classification
M
Marketing Category
C73584
G
Generic Name
KETOROLAC TROMETHAMINE
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateJuly 4, 2023
FDA Product Classification
INGREDIENTS (7)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
KETOROLAC TROMETHAMINEActive
Quantity: 60 mg in 1 mL
Code: 4EVE5946BQ
Classification: ACTIB