MIDAZOLAM
MIDAZOLAM
Approved
Approval ID
06090805-6a81-4179-9628-6d81bba66d6a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2022
Manufacturers
FDA
General Injectables and Vaccines, Inc.
DUNS: 108250663
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
midazoalm
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52584-749
Application NumberANDA090850
Product Classification
M
Marketing Category
C73584
G
Generic Name
midazoalm
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateDecember 28, 2022
FDA Product Classification
INGREDIENTS (6)
MIDAZOLAM HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: W7TTW573JJ
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT