Label: DULOXETINE capsule, delayed release
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NDC Code(s):
70771-1344-0,
70771-1344-3,
70771-1344-6,
70771-1344-9, view more70771-1345-0, 70771-1345-3, 70771-1345-9, 70771-1346-0, 70771-1346-3, 70771-1346-9
- 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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INGREDIENTS AND APPEARANCE
DULOXETINE
duloxetine capsule, delayed releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1344 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U) DULOXETINE 20 mg Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) AMMONIA (UNII: 5138Q19F1X) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) GELATIN (UNII: 2G86QN327L) HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6) HYPROMELLOSES (UNII: 3NXW29V3WO) ISOPROPYL ALCOHOL (UNII: ND2M416302) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color GREEN (GREEN) , WHITE (WHITE) Score no score Shape CAPSULE (CAPSULE) Size 14mm Flavor Imprint Code 385;20;mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1344-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/27/2014 2 NDC:70771-1344-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 05/27/2014 3 NDC:70771-1344-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/27/2014 4 NDC:70771-1344-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 04/06/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090728 05/27/2014 DULOXETINE
duloxetine capsule, delayed releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1345 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U) DULOXETINE 30 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) HYPROMELLOSES (UNII: 3NXW29V3WO) HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) ALCOHOL (UNII: 3K9958V90M) ISOPROPYL ALCOHOL (UNII: ND2M416302) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) AMMONIA (UNII: 5138Q19F1X) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color BLUE (BLUE) , GREEN (GREEN) Score no score Shape CAPSULE (CAPSULE) Size 16mm Flavor Imprint Code 386;30;mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1345-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/27/2014 2 NDC:70771-1345-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/27/2014 3 NDC:70771-1345-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 04/06/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090728 05/27/2014 DULOXETINE
duloxetine capsule, delayed releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1346 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U) DULOXETINE 60 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) HYPROMELLOSES (UNII: 3NXW29V3WO) HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) FD&C RED NO. 40 (UNII: WZB9127XOA) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) ALCOHOL (UNII: 3K9958V90M) ISOPROPYL ALCOHOL (UNII: ND2M416302) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) AMMONIA (UNII: 5138Q19F1X) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color BLUE (BLUE) , WHITE (WHITE) Score no score Shape CAPSULE (CAPSULE) Size 19mm Flavor Imprint Code 387;60;mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1346-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/27/2014 2 NDC:70771-1346-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/27/2014 3 NDC:70771-1346-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 04/06/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090728 05/27/2014 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1344, 70771-1345, 70771-1346) , MANUFACTURE(70771-1344, 70771-1345, 70771-1346)
