VENLAFAXINE HYDROCHLORIDE
These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1997
Approved
Approval ID
e901e476-58bd-4204-baaa-a4634ae65ab3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 18, 2020
Manufacturers
FDA
Annora Pharma Private Limited
DUNS: 650980746
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
VENLAFAXINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71785-1006
Application NumberANDA212277
Product Classification
M
Marketing Category
C73584
G
Generic Name
VENLAFAXINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 18, 2020
FDA Product Classification
INGREDIENTS (13)
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 37.5 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
VENLAFAXINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71785-1007
Application NumberANDA212277
Product Classification
M
Marketing Category
C73584
G
Generic Name
VENLAFAXINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 18, 2020
FDA Product Classification
INGREDIENTS (13)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM
VENLAFAXINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71785-1008
Application NumberANDA212277
Product Classification
M
Marketing Category
C73584
G
Generic Name
VENLAFAXINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 18, 2020
FDA Product Classification
INGREDIENTS (14)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT