Ketorolac Tromethamine

Basic Information

Product Name

FDA Product Code

55154-9366

Regulatory Information

NDC Product Code

55154-9366

Application Number

ANDA075784

Marketing Category

C73584

Effective Date

March 11, 2024

Territorial Authority

USA

FDA Title

Ketorolac Tromethamine Injection, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SODIUM CHLORIDE

Quantity: 6.68 mg in 1 mL

Code: 451W47IQ8X

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

KETOROLAC TROMETHAMINE

Quantity: 15 mg in 1 mL

Code: 4EVE5946BQ

Class Code: ACTIB

CITRIC ACID MONOHYDRATE

Quantity: 1 mg in 1 mL

Code: 2968PHW8QP

Class Code: IACT

Active Moieties

KETOROLAC

Code: YZI5105V0L

Basic Information

Regulatory Information

Company Information

Active Ingredients

SODIUM CHLORIDE

SODIUM HYDROXIDE

HYDROCHLORIC ACID

ALCOHOL

WATER

CITRIC ACID MONOHYDRATE

Active Moieties

KETOROLAC