Label: TADALAFIL tablet, film coated
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NDC Code(s):
70771-1475-0,
70771-1475-1,
70771-1475-3,
70771-1475-4, view more70771-1475-5, 70771-1475-9, 70771-1476-0, 70771-1476-1, 70771-1476-3, 70771-1476-4, 70771-1476-5, 70771-1476-7, 70771-1476-9, 70771-1477-0, 70771-1477-1, 70771-1477-3, 70771-1477-4, 70771-1477-5, 70771-1477-9, 70771-1478-0, 70771-1478-1, 70771-1478-3, 70771-1478-4, 70771-1478-5, 70771-1478-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 12, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1475-3 in bottle of 30 tablets
Tadalafil Tablets USP, 2.5 mg
Rx Only
30 tablets
NDC 70771-1476-3 in bottle of 30 tablets
Tadalafil Tablets USP, 5 mg
Rx Only
30 tablets
NDC 70771-1477-3 in bottle of 30 tablets
Tadalafil Tablets USP, 10 mg
Rx Only
30 tablets
NDC 70771-1478-3 in bottle of 30 tablets
Tadalafil Tablets USP, 20 mg
Rx Only
30 tablets
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INGREDIENTS AND APPEARANCE
TADALAFIL
tadalafil tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1475 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT) TADALAFIL 2.5 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color WHITE (WHITE) Score no score Shape CAPSULE (CAPSULE) Size 6mm Flavor Imprint Code T;1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1475-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2019 2 NDC:70771-1475-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2019 3 NDC:70771-1475-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2019 4 NDC:70771-1475-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2019 5 NDC:70771-1475-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2019 6 NDC:70771-1475-4 2 in 1 CARTON 03/27/2019 6 15 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 ANDA206693 03/27/2019 TADALAFIL
tadalafil tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1477 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT) TADALAFIL 10 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color YELLOW (YELLOW) Score no score Shape CAPSULE (CAPSULE) Size 10mm Flavor Imprint Code 898 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1477-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2019 2 NDC:70771-1477-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2019 3 NDC:70771-1477-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2019 4 NDC:70771-1477-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2019 5 NDC:70771-1477-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2019 6 NDC:70771-1477-4 2 in 1 CARTON 03/27/2019 6 15 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 ANDA206693 03/27/2019 TADALAFIL
tadalafil tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1478 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT) TADALAFIL 20 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color YELLOW (YELLOW) Score no score Shape OVAL (OVAL) Size 13mm Flavor Imprint Code 899 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1478-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2019 2 NDC:70771-1478-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2019 3 NDC:70771-1478-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2019 4 NDC:70771-1478-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2019 5 NDC:70771-1478-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2019 6 NDC:70771-1478-4 2 in 1 CARTON 03/27/2019 6 15 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 ANDA206693 03/27/2019 TADALAFIL
tadalafil tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1476 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT) TADALAFIL 5 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color YELLOW (YELLOW) Score no score Shape OVAL (OVAL) Size 8mm Flavor Imprint Code 897 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1476-7 10 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2019 2 NDC:70771-1476-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2019 3 NDC:70771-1476-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2019 4 NDC:70771-1476-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2019 5 NDC:70771-1476-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2019 6 NDC:70771-1476-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2019 7 NDC:70771-1476-4 2 in 1 CARTON 03/27/2019 7 15 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 ANDA206693 03/27/2019 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1475, 70771-1476, 70771-1477, 70771-1478) , MANUFACTURE(70771-1475, 70771-1476, 70771-1477, 70771-1478)