Midazolam
Midazolam Injection, USP
Approved
Approval ID
737361a0-8db1-4d3c-ba5e-44df3f49fa22
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2023
Manufacturers
FDA
Akorn
DUNS: 117693100
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Midazolam Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17478-524
Application NumberANDA075494
Product Classification
M
Marketing Category
C73584
G
Generic Name
Midazolam Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateJuly 31, 2012
FDA Product Classification
INGREDIENTS (7)
Midazolam HydrochlorideActive
Quantity: 5 mg in 1 mL
Code: W7TTW573JJ
Classification: ACTIM
Edetate DisodiumInactive
Quantity: 0.1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
Sodium ChlorideInactive
Quantity: 8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Benzyl AlcoholInactive
Quantity: 10 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
Midazolam Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17478-523
Application NumberANDA075494
Product Classification
M
Marketing Category
C73584
G
Generic Name
Midazolam Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateJuly 31, 2012
FDA Product Classification
INGREDIENTS (7)
Midazolam HydrochlorideActive
Quantity: 1 mg in 1 mL
Code: W7TTW573JJ
Classification: ACTIM
Edetate DisodiumInactive
Quantity: 0.1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
Sodium ChlorideInactive
Quantity: 8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
Benzyl AlcoholInactive
Quantity: 10 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT