FDA Product

KETOROLAC TROMETHAMINE

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

KETOROLAC TROMETHAMINE

FDA Product Code

72189-054

Regulatory Information

NDC Product Code

72189-054

Application Number

ANDA076109

Marketing Category

C73584

Effective Date

October 30, 2019

Territorial Authority

USA

FDA Title

KETOROLAC TROMETHAMINE

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerDIRECT RX

DUNS Number

079254320

Active Ingredients

OCTOXYNOL-40

Code: 9T1C662FKS

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

BENZALKONIUM CHLORIDE

Code: F5UM2KM3W7

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

KETOROLAC TROMETHAMINE

Quantity: 5 mg in 1 mL

Code: 4EVE5946BQ

Class Code: ACTIB

EDETATE DISODIUM

Code: 7FLD91C86K

Class Code: IACT

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

Active Moieties

KETOROLAC

Code: YZI5105V0L

EDETIC ACID

Code: 9G34HU7RV0

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy