Effexor XR (Page 13 of 13)

PRINCIPAL DISPLAY PANEL — 37.5 mg Capsule Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer
NDC 0008-0837-20

Effexor XR ®
(venlafaxine HCl)
Extended-Release Capsules

37.5 mg*

15 Capsules Rx only

Principal Display Panel -- 37.5 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 37.5 mg Capsule Blister Pack

Effexor XR®
(venlafaxine HCl)
Extended-Release Capsules37.5 mg

Wyeth® Phila. PA 19101

Principal Display Panel -- 37.5 mg Capsule Blister Pack
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 37.5 mg Capsule Blister Pack Carton

ALWAYS DISPENSE WITH MEDICATION GUIDE
NDC 0008-0837-03

Pfizer

Effexor XR ®
(venlafaxine HCl)
Extended-Release Capsules

37.5 mg*

10 Redipak® Blister
Strips of 10 Capsules100 Capsules

Rx only

Principal Display Panel -- 37.5 mg Capsule Blister Pack Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 75 mg Capsule Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 0008-0833-20

Pfizer

Effexor XR®
(venlafaxine HCl)Extended-Release Capsules

75 mg*

15 Capsules

Rx only

Principal Display Panel -- 75 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 75 mg Capsule Blister Pack

Effexor XR®
(venlafaxine HCl)
Extended-Release Capsules 75 mg

Wyeth® Phila. PA 19101

Principal Display Panel -- 75 mg Capsule Blister Pack
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 75 mg Capsule Blister Pack Carton

ALWAYS DISPENSE WITH MEDICATION GUIDE
NDC 0008-0833-03

Pfizer

Effexor XR ®
(venlafaxine HCl)
Extended-Release Capsules

75 mg*

10 Redipak® Blister
Strips of 10 Capsules100 Capsules

Rx only

Principal Display Panel -- 75 mg Capsule Blister Pack Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 150 mg Capsule Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 0008-0836-20

Pfizer

Effexor XR®
(venlafaxine HCl)Extended-Release Capsules

150 mg*

15 Capsules

Rx only

Principal Display Panel -- 150 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 150 mg Capsule Blister Pack

Effexor XR®
(venlafaxine HCl)
Extended-Release Capsules150 mg

Wyeth® Phila. PA 19101

Principal Display Panel -- 150 mg Capsule Blister Pack
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 150 mg Capsule Blister Pack Carton

ALWAYS DISPENSE WITH MEDICATION GUIDE
NDC 0008-0836-03

Pfizer

Effexor XR®
(venlafaxine HCl)
Extended-Release Capsules

150 mg*

10 Redipak® Blister
Strips of 10 Capsules100 Capsules

Rx only

Principal Display Panel -- 150 mg Capsule Blister Pack Carton
(click image for full-size original)
EFFEXOR XR venlafaxine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0008-0837
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) VENLAFAXINE 37.5 mg
Inactive Ingredients
Ingredient Name Strength
POWDERED CELLULOSE
GELATIN, UNSPECIFIED
FERRIC OXIDE RED
TITANIUM DIOXIDE
ETHYLCELLULOSE (100 MPA.S)
HYPROMELLOSE, UNSPECIFIED
HYPROMELLOSE 2910 (6 MPA.S)
Product Characteristics
Color ORANGE (PEACH) , GRAY (GRAY) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code W;EffexorXR;375
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0008-0837-20 15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:0008-0837-21 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:0008-0837-22 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:0008-0837-03 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0008-0837-02)
4 NDC:0008-0837-02 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (0008-0837-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020699 11/01/1997
EFFEXOR XR venlafaxine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0008-0833
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
POWDERED CELLULOSE
GELATIN, UNSPECIFIED
FERRIC OXIDE RED
TITANIUM DIOXIDE
ETHYLCELLULOSE (100 MPA.S)
HYPROMELLOSE, UNSPECIFIED
HYPROMELLOSE 2910 (6 MPA.S)
Product Characteristics
Color ORANGE (PEACH) Score no score
Shape CAPSULE (CAPSULE) Size 20mm
Flavor Imprint Code W;EffexorXR;75
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0008-0833-20 15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:0008-0833-21 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:0008-0833-22 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:0008-0833-03 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0008-0833-02)
4 NDC:0008-0833-02 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (0008-0833-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020699 11/01/1997
EFFEXOR XR venlafaxine hydrochloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0008-0836
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
POWDERED CELLULOSE
GELATIN, UNSPECIFIED
FERRIC OXIDE RED
TITANIUM DIOXIDE
ETHYLCELLULOSE (100 MPA.S)
HYPROMELLOSE, UNSPECIFIED
HYPROMELLOSE 2910 (6 MPA.S)
Product Characteristics
Color ORANGE (DARK ORANGE) Score no score
Shape CAPSULE (CAPSULE) Size 22mm
Flavor Imprint Code W;EffexorXR;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0008-0836-20 15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:0008-0836-21 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:0008-0836-22 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:0008-0836-03 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0008-0836-02)
4 NDC:0008-0836-02 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (0008-0836-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020699 11/01/1997
Labeler — Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. (113008515)
Establishment
Name Address ID/FEI Operations
Pfizer Pharmaceuticals LLC 829084552 LABEL (0008-0833), LABEL (0008-0836), LABEL (0008-0837), PACK (0008-0833), PACK (0008-0836), PACK (0008-0837)
Establishment
Name Address ID/FEI Operations
Pfizer Ireland Pharmaceuticals 986019327 ANALYSIS (0008-0833), ANALYSIS (0008-0836), ANALYSIS (0008-0837), MANUFACTURE (0008-0833), MANUFACTURE (0008-0836), MANUFACTURE (0008-0837)

Revised: 11/2019 Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

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