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Ketorolac Tromethamine

Ketorolac Tromethamine Injection, USP FOR INTRAVENOUS/INTRAMUSCULAR USE (15 mg and 30 mg) FOR INTRAMUSCULAR USE ONLY (60 mg)

Approved
Approval ID

3321b610-1c9b-4314-adbb-a2e163234dec

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 1, 2023

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

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 Code50090-6772
Application NumberANDA214456
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ketorolac Tromethamine
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateNovember 2, 2022
FDA Product Classification

INGREDIENTS (6)

KETOROLAC TROMETHAMINEActive
Quantity: 60 mg in 2 mL
Code: 4EVE5946BQ
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Ketorolac Tromethamine - FDA Drug Approval Details