MedPath

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

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