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

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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

//druginserts.com/lib/images-rx/desvenlafaxine-22/51407-022-30ol-300x231.jpg
(click image for full-size original)

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

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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.

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