Midazolam Hydrochloride
Midazolam CIV Injection, USP
Approved
Approval ID
1abda8b8-48a8-4995-af86-39220d1aa240
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 2, 2023
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
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 Code0409-2308
Application NumberANDA075857
Product Classification
M
Marketing Category
C73584
G
Generic Name
MIDAZOLAM HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 3, 2023
FDA Product Classification
INGREDIENTS (4)
MIDAZOLAM HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: W7TTW573JJ
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
MIDAZOLAM HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-2305
Application NumberANDA075857
Product Classification
M
Marketing Category
C73584
G
Generic Name
MIDAZOLAM HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 3, 2023
FDA Product Classification
INGREDIENTS (4)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
MIDAZOLAM HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: W7TTW573JJ
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT