Midazolam Hydrochloride
Midazolam Hydrochloride Syrup CIV
Approved
Approval ID
9a443652-6aff-4e27-83fe-90c65fa0f3c1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2023
Manufacturers
FDA
Precision Dose Inc.
DUNS: 035886746
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 Code68094-764
Application NumberANDA075873
Product Classification
M
Marketing Category
C73584
G
Generic Name
Midazolam Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (11)
Midazolam HydrochlorideActive
Quantity: 2 mg in 1 mL
Code: W7TTW573JJ
Classification: ACTIM
Edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
D&C Red No. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
Hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
sodium citrate, unspecified formInactive
Code: 1Q73Q2JULR
Classification: IACT
saccharin sodiumInactive
Code: SB8ZUX40TY
Classification: IACT
sorbitolInactive
Code: 506T60A25R
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
Anhydrous citric acidInactive
Code: XF417D3PSL
Classification: IACT