VENLAFAXINE HYDROCHLORIDE (Page 12 of 12)

PRINCIPAL DISPLAY PANEL — 150 mg Tablet Bottle Label

NDC 75834-218-00

Venlafaxine
Extended-Release
Tablets

150 mg

1000 Tablets

Pharmacist: Dispense the accompanying Medication Guide to each patient.

NIVAGEN

Rx only

PRINCIPAL DISPLAY PANEL -- 150 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 225 mg Tablet Bottle Label

NDC 75834-219-00

Venlafaxine
Extended-Release
Tablets

225 mg

1000 Tablets

Pharmacist: Dispense the accompanying Medication Guide to each patient.

NIVAGEN

Rx only

PRINCIPAL DISPLAY PANEL -- 225 mg Tablet Bottle Label
(click image for full-size original)
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75834-217
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) VENLAFAXINE 75 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE 2208 (100 MPA.S)
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
TALC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
SHELLAC
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
AMMONIA
MEDIUM-CHAIN TRIGLYCERIDES
HYPROMELLOSE 2910 (5 MPA.S)
ETHYLCELLULOSE (20 MPA.S)
POLYETHYLENE GLYCOL 8000
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code C46
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75834-217-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:75834-217-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:75834-217-00 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211323 09/06/2019
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75834-218
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) VENLAFAXINE 150 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
TALC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
SHELLAC
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
AMMONIA
MEDIUM-CHAIN TRIGLYCERIDES
HYPROMELLOSE 2208 (100 MPA.S)
ETHYLCELLULOSE (20 MPA.S)
POLYETHYLENE GLYCOL 8000
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code C34
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75834-218-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:75834-218-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:75834-218-00 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211323 09/06/2019
VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75834-219
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) VENLAFAXINE 225 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
TALC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
SHELLAC
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
AMMONIA
MEDIUM-CHAIN TRIGLYCERIDES
HYPROMELLOSE 2208 (100 MPA.S)
ETHYLCELLULOSE (20 MPA.S)
POLYETHYLENE GLYCOL 8000
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 12mm
Flavor Imprint Code C49
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75834-219-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:75834-219-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:75834-219-00 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211323 09/06/2019
Labeler — Nivagen Pharmaceuticals, Inc. (052032418)

Revised: 01/2021 Nivagen Pharmaceuticals, Inc.

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