Label: LANSOPRAZOLE tablet, orally disintegrating
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- NDC Code(s): 70771-1132-4, 70771-1133-4
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 18, 2022
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INGREDIENTS AND APPEARANCE
LANSOPRAZOLE
lansoprazole tablet, orally disintegratingProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1132 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG) LANSOPRAZOLE 15 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ASPARTAME (UNII: Z0H242BBR1) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) FERRIC OXIDE RED (UNII: 1K09F3G675) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYDROCHLORIC ACID (UNII: QTT17582CB) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM CARBONATE (UNII: 0E53J927NA) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) STRAWBERRY (UNII: 4J2TY8Y81V) TALC (UNII: 7SEV7J4R1U) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 10mm Flavor STRAWBERRY (STRAWBERRY) Imprint Code 771 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1132-4 10 in 1 CARTON 11/30/2018 1 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 ANDA200816 11/30/2018 LANSOPRAZOLE
lansoprazole tablet, orally disintegratingProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1133 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG) LANSOPRAZOLE 30 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ASPARTAME (UNII: Z0H242BBR1) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) FERRIC OXIDE RED (UNII: 1K09F3G675) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYDROCHLORIC ACID (UNII: QTT17582CB) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM CARBONATE (UNII: 0E53J927NA) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) STRAWBERRY (UNII: 4J2TY8Y81V) TALC (UNII: 7SEV7J4R1U) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 13mm Flavor STRAWBERRY (STRAWBERRY) Imprint Code 772 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1133-4 10 in 1 CARTON 11/30/2018 1 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 ANDA200816 11/30/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1132, 70771-1133) , MANUFACTURE(70771-1132, 70771-1133)
