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Midazolam hydrochloride

MIDAZOLAM HYDROCHLORIDE INJECTION, USP CIVFor intravenous or intramuscular use NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL

Approved
Approval ID

701581c3-5080-4557-b351-b59019d790e3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 5, 2017

Manufacturers
FDA

Wockhardt USA LLC.

DUNS: 170508365

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Midazolam hydrochloride

PRODUCT DETAILS

NDC Product Code64679-763
Application NumberANDA078141
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateDecember 5, 2017
Generic NameMidazolam hydrochloride

INGREDIENTS (6)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
MIDAZOLAM HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: W7TTW573JJ
Classification: ACTIM
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

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Midazolam hydrochloride - FDA Drug Approval Details