Pristiq Extended-Release (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 50 mg Tablet Blister Pack

NDC 0008-1211-50
Pristiq ®
(desvenlafaxine)

Extended-Release
Tablets
50 mg*

*Equivalent to 76 mg
desvenlafaxine succinateMADE IN SINGAPORE

PAA041479

Wyeth® Phila., PA 19101

Principal Display Panel -- 50 mg Tablet Blister Pack
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg Tablet Blister Pack Carton

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer
NDC 0008-1211-50

10 Redipak® Blister
Strips of 10 Tablets

Pristiq®
(desvenlafaxine)
Extended-Release Tablets

50 mg*

100 Tablets Rx only

Principal Display Panel -- 50 mg Tablet Blister Pack Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg Tablet Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer
NDC 0008-1211-30

Pristiq®
(desvenlafaxine)
Extended-Release Tablets

50 mg*

Unit of Use
30 Tablets Rx only

Principal Display Panel -- 50 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg Tablet Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer
NDC 0008-1222-30

Pristiq®
(desvenlafaxine)
Extended-Release Tablets

100 mg*

Unit of Use
30 Tablets Rx only

Principal Display Panel -- 100 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg Tablet Blister Pack

NDC 0008-1222-50
Pristiq ®
(desvenlafaxine)

Extended-Release
Tablets
100 mg*

*Equivalent to 152 mg
desvenlafaxine succinateMADE IN SINGAPORE

PAA041470

Wyeth® Phila., PA 19101

Principal Display Panel -- 100 mg Tablet Blister Pack
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg Tablet Blister Pack Carton

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer
NDC 0008-1222-50

10 Redipak® Blister
Strips of 10 Tablets

Pristiq®
(desvenlafaxine)
Extended-Release Tablets

100 mg*

100 Tablets Rx only

Principal Display Panel -- 100 mg Tablet Blister Pack Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 25 mg Tablet Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer
NDC 0008-1210-30

Pristiq®
(desvenlafaxine)
Extended-Release Tablets

25 mg*

Unit of Use
30 Tablets Rx only

Principal Display Panel -- 25 mg Tablet Bottle Label
(click image for full-size original)
PRISTIQ EXTENDED-RELEASE desvenlafaxine succinate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0008-1211
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
MICROCRYSTALLINE CELLULOSE
TALC
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
FERRIC OXIDE RED
POLYVINYL ALCOHOL, UNSPECIFIED
FERRIC OXIDE YELLOW
HYPROMELLOSE 2208 (15000 MPA.S)
Product Characteristics
Color PINK (LIGHT PINK) Score no score
Shape SQUARE (SQUARE PYRAMID) Size 8mm
Flavor Imprint Code W;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0008-1211-50 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (0008-1211-50)
2 NDC:0008-1211-01 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
3 NDC:0008-1211-14 14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
4 NDC:0008-1211-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021992 05/01/2008
PRISTIQ EXTENDED-RELEASE desvenlafaxine succinate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0008-1222
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
MICROCRYSTALLINE CELLULOSE
TALC
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
FERRIC OXIDE YELLOW
FD&C YELLOW NO. 6
HYPROMELLOSE 2208 (15000 MPA.S)
Product Characteristics
Color ORANGE (REDDISH-ORANGE) Score no score
Shape SQUARE (SQUARE PYRAMID) Size 9mm
Flavor Imprint Code W;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0008-1222-01 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:0008-1222-14 14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
3 NDC:0008-1222-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
4 NDC:0008-1222-50 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (0008-1222-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021992 05/01/2008
PRISTIQ EXTENDED-RELEASE desvenlafaxine succinate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0008-1210
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
MICROCRYSTALLINE CELLULOSE
TALC
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
FERRIC OXIDE RED
POLYVINYL ALCOHOL, UNSPECIFIED
FERRIC OXIDE YELLOW
HYPROMELLOSE 2208 (15000 MPA.S)
Product Characteristics
Color BROWN (tan) Score no score
Shape SQUARE (SQUARE PYRAMID) Size 8mm
Flavor Imprint Code W;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0008-1210-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021992 04/01/2015
Labeler — Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. (113008515)
Registrant — Pfizer Inc (113480771)
Establishment
Name Address ID/FEI Operations
Sharp Corporation 143696495 PACK (0008-1210), PACK (0008-1211), PACK (0008-1222), LABEL (0008-1210), LABEL (0008-1211), LABEL (0008-1222)
Establishment
Name Address ID/FEI Operations
Pfizer Pharmaceuticals LLC 829084552 PACK (0008-1210), PACK (0008-1211), PACK (0008-1222), LABEL (0008-1210), LABEL (0008-1211), LABEL (0008-1222)
Establishment
Name Address ID/FEI Operations
Pfizer Asia Manufacturing Pte Ltd 936889401 ANALYSIS (0008-1210), ANALYSIS (0008-1211), ANALYSIS (0008-1222), API MANUFACTURE (0008-1210), API MANUFACTURE (0008-1211), API MANUFACTURE (0008-1222)
Establishment
Name Address ID/FEI Operations
Pfizer Ireland Pharmaceuticals 986019327 ANALYSIS (0008-1210), ANALYSIS (0008-1211), ANALYSIS (0008-1222), MANUFACTURE (0008-1210), MANUFACTURE (0008-1211), MANUFACTURE (0008-1222)
Establishment
Name Address ID/FEI Operations
Pfizer Ireland Pharmaceuticals 985052076 ANALYSIS (0008-1210), ANALYSIS (0008-1211), ANALYSIS (0008-1222), API MANUFACTURE (0008-1210), API MANUFACTURE (0008-1211), API MANUFACTURE (0008-1222)

Revised: 11/2021 Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.