VENLAFAXINE tablet, extended release
Venlafaxine by
Drug Labeling and Warnings
Venlafaxine by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
- SPL MEDGUIDE
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Venlafaxine extended-release tablets, 37.5 mg
NDC: 70771-1649-3
30 Tablets
Rx only
Venlafaxine extended-release tablets, 75 mg
NDC: 70771-1650-3
30 Tablets
Rx only
Venlafaxine extended-release tablets, 150 mg
NDC: 70771-1651-3
30 Tablets
Rx only
Venlafaxine extended-release tablets, 225 mg
NDC: 70771-1652-3
30 Tablets
Rx only
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INGREDIENTS AND APPEARANCE
VENLAFAXINE
venlafaxine tablet, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1649 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE 37.5 mg Inactive Ingredients Ingredient Name Strength CELLULOSE ACETATE (UNII: 3J2P07GVB6) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K90 (UNII: RDH86HJV5Z) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color WHITE (off-white) Score no score Shape ROUND Size 6mm Flavor Imprint Code 1348 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70771-1649-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2022 2 NDC: 70771-1649-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2022 3 NDC: 70771-1649-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215622 09/01/2022 VENLAFAXINE
venlafaxine tablet, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1650 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE 75 mg Inactive Ingredients Ingredient Name Strength CELLULOSE ACETATE (UNII: 3J2P07GVB6) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K90 (UNII: RDH86HJV5Z) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color WHITE (off-white) Score no score Shape ROUND Size 8mm Flavor Imprint Code 1349 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70771-1650-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2022 2 NDC: 70771-1650-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2022 3 NDC: 70771-1650-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215622 09/01/2022 VENLAFAXINE
venlafaxine tablet, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1651 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE 150 mg Inactive Ingredients Ingredient Name Strength CELLULOSE ACETATE (UNII: 3J2P07GVB6) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K90 (UNII: RDH86HJV5Z) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color WHITE (off-white) Score no score Shape ROUND Size 10mm Flavor Imprint Code 1350 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70771-1651-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2022 2 NDC: 70771-1651-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2022 3 NDC: 70771-1651-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215622 09/01/2022 VENLAFAXINE
venlafaxine tablet, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1652 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VENLAFAXINE HYDROCHLORIDE (UNII: 7D7RX5A8MO) (VENLAFAXINE - UNII:GRZ5RCB1QG) VENLAFAXINE 225 mg Inactive Ingredients Ingredient Name Strength CELLULOSE ACETATE (UNII: 3J2P07GVB6) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K90 (UNII: RDH86HJV5Z) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color WHITE (off-white) Score no score Shape ROUND Size 12mm Flavor Imprint Code 1352 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70771-1652-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2022 2 NDC: 70771-1652-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2022 3 NDC: 70771-1652-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215622 09/01/2022 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1649, 70771-1650, 70771-1651, 70771-1652) , MANUFACTURE(70771-1649, 70771-1650, 70771-1651, 70771-1652)
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