Midazolam Hydrochloride
MIDAZOLAM HYDROCHLORIDE SYRUP CIV For oral use
Approved
Approval ID
1a701d59-3a30-4a4b-a5dd-51f01ba9c5cc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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
NDC Product Code72162-1109
Application NumberANDA076379
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 25, 2023
Generic NameMidazolam Hydrochloride
INGREDIENTS (10)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
MIDAZOLAM HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: W7TTW573JJ
Classification: ACTIM
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT