Midazolam
Midazolam Injection, USP
Approved
Approval ID
8675cdb1-c7f5-40cf-b1e0-0960b7ab117b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 7, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 946499746
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Midazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0641-6209
Application NumberANDA075243
Product Classification
M
Marketing Category
C73584
G
Generic Name
Midazolam
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 7, 2023
FDA Product Classification
INGREDIENTS (7)
SODIUM CHLORIDEInactive
Quantity: 8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 10 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MIDAZOLAM HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: W7TTW573JJ
Classification: ACTIM
Midazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0641-6210
Application NumberANDA075243
Product Classification
M
Marketing Category
C73584
G
Generic Name
Midazolam
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 7, 2023
FDA Product Classification
INGREDIENTS (7)
MIDAZOLAM HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: W7TTW573JJ
Classification: ACTIM
SODIUM CHLORIDEInactive
Quantity: 8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 10 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Midazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0641-6211
Application NumberANDA075243
Product Classification
M
Marketing Category
C73584
G
Generic Name
Midazolam
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 7, 2023
FDA Product Classification
INGREDIENTS (7)
SODIUM CHLORIDEInactive
Quantity: 8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
MIDAZOLAM HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: W7TTW573JJ
Classification: ACTIM
BENZYL ALCOHOLInactive
Quantity: 10 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT