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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

NDC Product Code50090-6772
Application NumberANDA214456
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateNovember 2, 2022
Generic NameKetorolac Tromethamine

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 Approval | MedPath