Label: DESVENLAFAXINE tablet, extended release
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NDC Code(s):
70771-1311-0,
70771-1311-1,
70771-1311-2,
70771-1311-3, view more70771-1311-4, 70771-1311-5, 70771-1311-7, 70771-1311-9, 70771-1312-0, 70771-1312-1, 70771-1312-2, 70771-1312-3, 70771-1312-4, 70771-1312-5, 70771-1312-7, 70771-1312-9, 70771-1661-3, 70771-1661-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 21, 2023
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Desvenlafaxine Extended-release Tablets, 25 mg
NDC 70771-1661-3
30 tablets
Rx only
NDC 68382-469-67 in bottle of 14 tablets in unit-of-use package
Desvenlafaxine Extended-release Tablets, 50 mg
14 tablets
Rx only
Zydus
NDC 68382-741-67 in bottle of 14 tablets in unit-of-use package
Desvenlafaxine Extended-release Tablets, 100 mg
14 tablets
Rx only
Zydus
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INGREDIENTS AND APPEARANCE
DESVENLAFAXINE
desvenlafaxine tablet, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1311 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DESVENLAFAXINE (UNII: NG99554ANW) (DESVENLAFAXINE - UNII:NG99554ANW) DESVENLAFAXINE 50 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape SQUARE (SQUARE) Size 9mm Flavor Imprint Code 469 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1311-7 14 in 1 BOTTLE; Type 0: Not a Combination Product 05/08/2018 2 NDC:70771-1311-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/08/2018 3 NDC:70771-1311-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/08/2018 4 NDC:70771-1311-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/08/2018 5 NDC:70771-1311-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/08/2018 6 NDC:70771-1311-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 05/08/2018 7 NDC:70771-1311-4 10 in 1 CARTON 05/08/2018 7 NDC:70771-1311-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204020 05/08/2018 DESVENLAFAXINE
desvenlafaxine tablet, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1312 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DESVENLAFAXINE (UNII: NG99554ANW) (DESVENLAFAXINE - UNII:NG99554ANW) DESVENLAFAXINE 100 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color ORANGE (ORANGE) Score no score Shape SQUARE (SQUARE) Size 9mm Flavor Imprint Code 741 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1312-7 14 in 1 BOTTLE; Type 0: Not a Combination Product 05/08/2018 2 NDC:70771-1312-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/08/2018 3 NDC:70771-1312-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/08/2018 4 NDC:70771-1312-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/08/2018 5 NDC:70771-1312-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/08/2018 6 NDC:70771-1312-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 05/08/2018 7 NDC:70771-1312-4 10 in 1 CARTON 05/08/2018 7 NDC:70771-1312-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204020 05/08/2018 DESVENLAFAXINE
desvenlafaxine tablet, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1661 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DESVENLAFAXINE (UNII: NG99554ANW) (DESVENLAFAXINE - UNII:NG99554ANW) DESVENLAFAXINE 25 mg Inactive Ingredients Ingredient Name Strength FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color YELLOW (Light Yellow to Yellow) Score no score Shape SQUARE (Square) Size 9mm Flavor Imprint Code 1257 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1661-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/30/2022 2 NDC:70771-1661-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/30/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204020 11/30/2022 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1311, 70771-1312, 70771-1661) , MANUFACTURE(70771-1311, 70771-1312, 70771-1661)