Label: SERTRALINE HYDROCHLORIDE tablet, film coated
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NDC Code(s):
65841-043-01,
65841-043-05,
65841-043-06,
65841-043-10, view more65841-043-14, 65841-043-16, 65841-043-18, 65841-044-01, 65841-044-05, 65841-044-06, 65841-044-10, 65841-044-14, 65841-044-16, 65841-045-01, 65841-045-06, 65841-045-14, 65841-045-16, 65841-045-40
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 27, 2023
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INGREDIENTS AND APPEARANCE
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-043 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SERTRALINE HYDROCHLORIDE (UNII: UTI8907Y6X) (SERTRALINE - UNII:QUC7NX6WMB) SERTRALINE 25 mg Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color GREEN (LIGHT GREEN) Score 2 pieces Shape ROUND (ROUND) Size 6mm Flavor Imprint Code Z;82 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-043-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 2 NDC:65841-043-18 50 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 3 NDC:65841-043-14 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 4 NDC:65841-043-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 5 NDC:65841-043-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 6 NDC:65841-043-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 7 NDC:65841-043-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077106 12/02/2017 SERTRALINE HYDROCHLORIDE
sertraline hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-044 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SERTRALINE HYDROCHLORIDE (UNII: UTI8907Y6X) (SERTRALINE - UNII:QUC7NX6WMB) SERTRALINE 50 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color BLUE (LIGHT BLUE) Score 2 pieces Shape ROUND (ROUND) Size 8mm Flavor Imprint Code Z;81 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-044-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 2 NDC:65841-044-14 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 3 NDC:65841-044-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 4 NDC:65841-044-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 5 NDC:65841-044-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 6 NDC:65841-044-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077106 12/02/2017 SERTRALINE HYDROCHLORIDE
sertraline hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-045 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SERTRALINE HYDROCHLORIDE (UNII: UTI8907Y6X) (SERTRALINE - UNII:QUC7NX6WMB) SERTRALINE 100 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color YELLOW (YELLOW) Score 2 pieces Shape ROUND (ROUND) Size 10mm Flavor Imprint Code Z;80 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-045-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 2 NDC:65841-045-14 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 3 NDC:65841-045-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 4 NDC:65841-045-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 5 NDC:65841-045-40 5000 in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077106 12/02/2017 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-043, 65841-044, 65841-045) , MANUFACTURE(65841-043, 65841-044, 65841-045)
