Label: VENLAFAXINE HYDROCHLORIDE capsule, extended release
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NDC Code(s):
65841-751-06,
65841-751-10,
65841-751-16,
65841-752-06, view more65841-752-10, 65841-752-16, 65841-753-06, 65841-753-10, 65841-753-16
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 28, 2023
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INGREDIENTS AND APPEARANCE
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride capsule, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-751 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 FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYPROMELLOSES (UNII: 3NXW29V3WO) GELATIN (UNII: 2G86QN327L) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) (UNII: P2OM2Q86BI) Product Characteristics Color GRAY (GRAY) , WHITE (WHITE) Score no score Shape CAPSULE (CAPSULE) Size 16mm Flavor Imprint Code ZA;35;37;5;mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-751-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2011 2 NDC:65841-751-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2011 3 NDC:65841-751-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090174 06/01/2011 VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride capsule, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-752 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 FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYPROMELLOSES (UNII: 3NXW29V3WO) GELATIN (UNII: 2G86QN327L) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) FERRIC OXIDE RED (UNII: 1K09F3G675) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) (UNII: P2OM2Q86BI) Product Characteristics Color ORANGE (PEACH) , WHITE (WHITE) Score no score Shape CAPSULE (CAPSULE) Size 20mm Flavor Imprint Code ZA;36;75;mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-752-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2011 2 NDC:65841-752-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2011 3 NDC:65841-752-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090174 06/01/2011 VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride capsule, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-753 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 FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYPROMELLOSES (UNII: 3NXW29V3WO) GELATIN (UNII: 2G86QN327L) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) FERRIC OXIDE RED (UNII: 1K09F3G675) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) (UNII: P2OM2Q86BI) Product Characteristics Color ORANGE (DARK ORANGE) , WHITE (WHITE) Score no score Shape CAPSULE (CAPSULE) Size 21mm Flavor Imprint Code ZA;37;150;mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-753-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2011 2 NDC:65841-753-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2011 3 NDC:65841-753-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090174 06/01/2011 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-751, 65841-752, 65841-753) , MANUFACTURE(65841-751, 65841-752, 65841-753)
