NEFAZODONE HYDROCHLORIDE
Approved
Approval ID
30f2dc3f-a5da-40da-9314-12935cbdac7d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 7, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NEFAZODONE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-166
Application NumberANDA076037
Product Classification
M
Marketing Category
C73584
G
Generic Name
NEFAZODONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateApril 7, 2011
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
NEFAZODONE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 27X63J94GR
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT