Nefazodone Hydrochloride
Nefazodone Hydrochloride Tablets, USP Rx only (Patient Information Included)
Approved
Approval ID
51ff7db5-aaf9-4c3c-86e6-958ebf16b60f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2021
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
Products 5
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 Code0093-1024
Application NumberANDA076037
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nefazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2021
FDA Product Classification
INGREDIENTS (6)
NEFAZODONE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 27X63J94GR
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Nefazodone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-7178
Application NumberANDA076037
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nefazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2021
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
NEFAZODONE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 27X63J94GR
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Nefazodone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-7113
Application NumberANDA076037
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nefazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2021
FDA Product Classification
INGREDIENTS (8)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
NEFAZODONE HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: 27X63J94GR
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Nefazodone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-1026
Application NumberANDA076037
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nefazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2021
FDA Product Classification
INGREDIENTS (6)
NEFAZODONE HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: 27X63J94GR
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
Nefazodone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-1025
Application NumberANDA076037
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nefazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2021
FDA Product Classification
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
NEFAZODONE HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: 27X63J94GR
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT