Fluphenazine Hydrochloride
Fluphenazine Hydrochloride Oral Solution USP (Concentrate)
Approved
Approval ID
0860b3f3-3116-40f8-bcb0-e5c47731bdc8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2022
Manufacturers
FDA
Pharmaceutical Associates, Inc.
DUNS: 044940096
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluphenazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0121-0653
Application NumberANDA074725
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluphenazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2022
FDA Product Classification
INGREDIENTS (5)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
FLUPHENAZINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: ZOU145W1XL
Classification: ACTIB