Midazolam
Midazolam Injection, USP
Approved
Approval ID
473fba4b-8754-4b1d-bba9-d9c8f6d818e0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2023
Manufacturers
FDA
Steriscience Specialties Private Limited
DUNS: 853179150
Products 3
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 Code82449-207
Application NumberANDA090316
Product Classification
M
Marketing Category
C73584
G
Generic Name
midazolam hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateDecember 13, 2023
FDA Product Classification
INGREDIENTS (6)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
MIDAZOLAM HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: W7TTW573JJ
Classification: ACTIM
midazolam hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82449-208
Application NumberANDA090316
Product Classification
M
Marketing Category
C73584
G
Generic Name
midazolam hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateDecember 13, 2023
FDA Product Classification
INGREDIENTS (6)
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
MIDAZOLAM HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: W7TTW573JJ
Classification: ACTIM
midazolam hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82449-209
Application NumberANDA090316
Product Classification
M
Marketing Category
C73584
G
Generic Name
midazolam hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateDecember 13, 2023
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
MIDAZOLAM HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: W7TTW573JJ
Classification: ACTIM