Desvenlafaxine: Package Insert and Label Information (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51407-021-30
Desvenlafaxine Extended-Release Tablets
25 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

30 Tablets Rx Only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51407-022-30
Desvenlafaxine Extended-Release Tablets
50 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

30 Tablets Rx Only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51407-023-30
Desvenlafaxine Extended-Release Tablets
100 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

30 Tablets Rx Only

DESVENLAFAXINE desvenlafaxine tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-021(NDC:0591-4060) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DESVENLAFAXINE SUCCINATE (DESVENLAFAXINE) DESVENLAFAXINE 25 mg

Inactive Ingredients Ingredient Name Strength HYPROMELLOSES MICROCRYSTALLINE CELLULOSE TALC MAGNESIUM STEARATE POLYETHYLENE GLYCOL 900000 SILICON DIOXIDE POLYVINYL ALCOHOL, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE FERRIC OXIDE YELLOW FERRIC OXIDE RED PROPYLENE GLYCOL FERROSOFERRIC OXIDE

Product Characteristics Color pink (light pink) Score no score Shape SQUARE (square pyramid) Size 9mm Flavor Imprint Code A112 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:51407-021-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204065 07/29/2016 09/30/2020

DESVENLAFAXINE desvenlafaxine tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-022(NDC:0591-3659) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DESVENLAFAXINE SUCCINATE (DESVENLAFAXINE) DESVENLAFAXINE 50 mg

Inactive Ingredients Ingredient Name Strength HYPROMELLOSES MICROCRYSTALLINE CELLULOSE TALC MAGNESIUM STEARATE POLYETHYLENE GLYCOL 900000 SILICON DIOXIDE POLYVINYL ALCOHOL, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE FERRIC OXIDE YELLOW FERRIC OXIDE RED PROPYLENE GLYCOL FERROSOFERRIC OXIDE

Product Characteristics Color pink (light pink) Score no score Shape SQUARE (square pyramid) Size 12mm Flavor Imprint Code WPI;3659 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:51407-022-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:51407-022-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204065 07/29/2016

DESVENLAFAXINE desvenlafaxine tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-023(NDC:0591-3660) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DESVENLAFAXINE SUCCINATE (DESVENLAFAXINE) DESVENLAFAXINE 100 mg

Inactive Ingredients Ingredient Name Strength HYPROMELLOSES MICROCRYSTALLINE CELLULOSE TALC MAGNESIUM STEARATE POLYETHYLENE GLYCOL 900000 SILICON DIOXIDE POLYVINYL ALCOHOL, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE FERRIC OXIDE YELLOW FERRIC OXIDE RED PROPYLENE GLYCOL FERROSOFERRIC OXIDE

Product Characteristics Color red (reddish-orange) Score no score Shape SQUARE (square pyramid) Size 12mm Flavor Imprint Code WPI;3660 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:51407-023-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:51407-023-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204065 07/29/2016

Labeler — Golden State Medical Supply, Inc. (603184490)

Establishment
Name	Address	ID/FEI	Operations
Golden State Medical Supply, Inc.		603184490	relabel (51407-021), repack (51407-021), relabel (51407-022), repack (51407-022), relabel (51407-023), repack (51407-023)

Revised: 01/2021 Golden State Medical Supply, Inc.