FDA Product

Midazolam Hydrochloride

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

Basic Information

Product Name

Midazolam Hydrochloride

FDA Product Code

55154-4743

Regulatory Information

NDC Product Code

55154-4743

Application Number

ANDA075857

Marketing Category

C73584

Effective Date

January 9, 2018

Territorial Authority

USA

FDA Title

Midazolam CIV Injection, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

4

Company Information

ManufacturerCardinal Health 107, LLC

DUNS Number

118546603

Active Ingredients

SODIUM CHLORIDE

Quantity: 8 mg in 1 mL

Code: 451W47IQ8X

Class Code: IACT

MIDAZOLAM HYDROCHLORIDE

Quantity: 1 mg in 1 mL

Code: W7TTW573JJ

Class Code: ACTIM

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

Active Moieties

MIDAZOLAM

Code: R60L0SM5BC

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