VENLAFAXINE HYDROCHLORIDE (Page 11 of 11)

37.5 mg

37.5 mg- 500 ct
(click image for full-size original)

75 mg

75 mg- 500 ct
(click image for full-size original)

150 mg

150 mg- 500 ct
(click image for full-size original)

225 mg

225 mg- 500 ct
(click image for full-size original)

VENLAFAXINE HYDROCHLORIDE
venlafaxine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43602-392
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
MANNITOL
MICROCRYSTALLINE CELLULOSE
POVIDONE
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 8000
POLYETHYLENE GLYCOL 3350
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE ACETATE
HYPROMELLOSES
TITANIUM DIOXIDE
TALC
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 392
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43602-392-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:43602-392-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214419 10/23/2020
VENLAFAXINE HYDROCHLORIDE
venlafaxine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43602-393
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
MANNITOL
MICROCRYSTALLINE CELLULOSE
POVIDONE
POLYETHYLENE GLYCOL 400
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE ACETATE
HYPROMELLOSES
POLYETHYLENE GLYCOL 3350
TITANIUM DIOXIDE
TALC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
POLYETHYLENE GLYCOL 8000
Product Characteristics
Color white Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 393
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43602-393-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:43602-393-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214419 10/23/2020
VENLAFAXINE HYDROCHLORIDE
venlafaxine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43602-394
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
MANNITOL
MICROCRYSTALLINE CELLULOSE
POVIDONE
POLYETHYLENE GLYCOL 400
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE ACETATE
HYPROMELLOSES
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
TALC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
Product Characteristics
Color white Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 394
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43602-394-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:43602-394-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214419 10/23/2020
VENLAFAXINE HYDROCHLORIDE
venlafaxine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43602-395
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
MANNITOL
MICROCRYSTALLINE CELLULOSE
POVIDONE
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 8000
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE ACETATE
HYPROMELLOSES
TITANIUM DIOXIDE
TALC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
Product Characteristics
Color white Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 395
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43602-395-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:43602-395-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214419 10/23/2020
Labeler — Ascent Pharmaceuticals, Inc. (080938961)
Establishment
Name Address ID/FEI Operations
Ascent Pharmaceuticals, Inc. 080938961 analysis (43602-392), analysis (43602-393), analysis (43602-394), analysis (43602-395), manufacture (43602-392), manufacture (43602-393), manufacture (43602-394), manufacture (43602-395), pack (43602-392), pack (43602-393), pack (43602-394), pack (43602-395)

Revised: 10/2020 Ascent Pharmaceuticals, Inc.

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