Midazolam Hydrochloride
MIDAZOLAM HYDROCHLORIDE SYRUP CIV For oral use
Approved
Approval ID
2d62891b-06e1-4c21-bb7d-73b6aa19eb22
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 5, 2023
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
Products 1
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 Code0904-7113
Application NumberANDA075873
Product Classification
M
Marketing Category
C73584
G
Generic Name
Midazolam Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 28, 2021
FDA Product Classification
INGREDIENTS (11)
MIDAZOLAM HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: W7TTW573JJ
Classification: ACTIM
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT