Fluphenazine Hydrochloride
Approved
Approval ID
2a8ef5f7-c806-470d-96ff-3b3827dc8938
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2011
Manufacturers
FDA
TYA Pharmaceuticals
DUNS: 938389038
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 Code64725-2810
Application NumberANDA089556
Product Classification
M
Marketing Category
C73584
G
Generic Name
FLUPHENAZINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJanuary 4, 2011
FDA Product Classification
INGREDIENTS (6)
FLUPHENAZINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 mL
Code: ZOU145W1XL
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
METHYLPARABENInactive
Quantity: 1 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.1 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT