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 — 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

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.