Label: OLANZAPINE tablet, orally disintegrating
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NDC Code(s):
70771-1814-0,
70771-1814-1,
70771-1814-3,
70771-1814-5, view more70771-1814-9, 70771-1815-0, 70771-1815-1, 70771-1815-3, 70771-1815-5, 70771-1815-9, 70771-1816-0, 70771-1816-1, 70771-1816-3, 70771-1816-5, 70771-1816-9, 70771-1817-0, 70771-1817-1, 70771-1817-3, 70771-1817-5, 70771-1817-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 3, 2024
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INGREDIENTS AND APPEARANCE
OLANZAPINE
olanzapine tablet, orally disintegratingProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1814 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR) OLANZAPINE 5 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH) MANNITOL (UNII: 3OWL53L36A) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) ORANGE (UNII: 5EVU04N5QU) CROSPOVIDONE (UNII: 2S7830E561) Product Characteristics Color YELLOW (Light Yellow toYellow) Score no score Shape ROUND (round) Size 6mm Flavor ORANGE (orange) Imprint Code 516 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1814-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2025 2 NDC:70771-1814-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2025 3 NDC:70771-1814-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2025 4 NDC:70771-1814-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2025 5 NDC:70771-1814-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202889 01/18/2025 OLANZAPINE
olanzapine tablet, orally disintegratingProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1815 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR) OLANZAPINE 10 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSPOVIDONE (UNII: 2S7830E561) DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) ORANGE (UNII: 5EVU04N5QU) Product Characteristics Color YELLOW (Light Yellow to Yellow) Score no score Shape ROUND (round) Size 7mm Flavor ORANGE (orange) Imprint Code 517 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1815-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2025 2 NDC:70771-1815-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2025 3 NDC:70771-1815-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2025 4 NDC:70771-1815-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2025 5 NDC:70771-1815-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202889 01/18/2025 OLANZAPINE
olanzapine tablet, orally disintegratingProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1816 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR) OLANZAPINE 15 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSPOVIDONE (UNII: 2S7830E561) DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) ORANGE (UNII: 5EVU04N5QU) Product Characteristics Color YELLOW (Light Yellow to Yellow) Score no score Shape ROUND (round) Size 9mm Flavor ORANGE (orange) Imprint Code 518 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1816-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2025 2 NDC:70771-1816-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2025 3 NDC:70771-1816-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2025 4 NDC:70771-1816-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2025 5 NDC:70771-1816-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202889 01/18/2025 OLANZAPINE
olanzapine tablet, orally disintegratingProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1817 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR) OLANZAPINE 20 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSPOVIDONE (UNII: 2S7830E561) DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) ORANGE (UNII: 5EVU04N5QU) Product Characteristics Color YELLOW (Light Yellow to Yellow) Score no score Shape ROUND (round) Size 10mm Flavor ORANGE (orange) Imprint Code 519 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1817-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2025 2 NDC:70771-1817-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2025 3 NDC:70771-1817-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2025 4 NDC:70771-1817-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2025 5 NDC:70771-1817-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/18/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202889 01/18/2025 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1814, 70771-1815, 70771-1816, 70771-1817) , MANUFACTURE(70771-1814, 70771-1815, 70771-1816, 70771-1817)
