Label: OLANZAPINE tablet, film coated

  • NDC Code(s): 70771-1416-0, 70771-1416-1, 70771-1416-2, 70771-1416-3, view more
    70771-1416-4, 70771-1416-6, 70771-1417-0, 70771-1417-1, 70771-1417-2, 70771-1417-3, 70771-1417-4, 70771-1417-6, 70771-1418-0, 70771-1418-1, 70771-1418-2, 70771-1418-3, 70771-1418-4, 70771-1418-6, 70771-1419-0, 70771-1419-1, 70771-1419-2, 70771-1419-3, 70771-1419-4, 70771-1419-6, 70771-1420-0, 70771-1420-1, 70771-1420-2, 70771-1420-3, 70771-1420-4, 70771-1420-6, 70771-1421-0, 70771-1421-1, 70771-1421-2, 70771-1421-3, 70771-1421-4, 70771-1421-6
  • 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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  • SPL UNCLASSIFIED SECTION

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1416-0 in bottle of 1,000 tablets

    Olanzapine Tablets USP, 2.5 mg

    Rx only

    1,000 tablets

    2.5 mg label

    NDC 70771-1417-0 in bottle of 1,000 tablets

    Olanzapine Tablets USP, 5 mg

    Rx only

    1,000 tablets

    5 mg label

    NDC 70771-1418-0 in bottle of 1,000 tablets

    Olanzapine Tablets USP, 7.5 mg

    Rx only

    1,000 tablets

    7.5 mg label

    NDC 70771-1419-0 in bottle of 1,000 tablets

    Olanzapine Tablets USP, 10 mg

    Rx only

    1,000 tablets

    10 mg label

    NDC 70771-1420-0 in bottle of 1,000 tablets

    Olanzapine Tablets USP, 15 mg

    Rx only

    1,000 tablets

    15 mg label

    NDC 70771-1421-0 in bottle of 1,000 tablets

    Olanzapine Tablets USP, 20 mg

    Rx only

    1,000 tablets

    20 mg label
  • INGREDIENTS AND APPEARANCE
    OLANZAPINE 
    olanzapine tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1416
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR) OLANZAPINE2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code ZF28
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1416-330 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    2NDC:70771-1416-660 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    3NDC:70771-1416-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    4NDC:70771-1416-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    5NDC:70771-1416-410 in 1 CARTON01/03/2019
    5NDC:70771-1416-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09045901/03/2019
    OLANZAPINE 
    olanzapine tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1417
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR) OLANZAPINE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code ZF29
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1417-330 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    2NDC:70771-1417-660 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    3NDC:70771-1417-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    4NDC:70771-1417-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    5NDC:70771-1417-410 in 1 CARTON01/03/2019
    5NDC:70771-1417-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09045901/03/2019
    OLANZAPINE 
    olanzapine tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1418
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR) OLANZAPINE7.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code ZF30
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1418-330 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    2NDC:70771-1418-660 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    3NDC:70771-1418-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    4NDC:70771-1418-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    5NDC:70771-1418-410 in 1 CARTON01/03/2019
    5NDC:70771-1418-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09045901/03/2019
    OLANZAPINE 
    olanzapine tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1419
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR) OLANZAPINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code ZF31
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1419-330 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    2NDC:70771-1419-660 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    3NDC:70771-1419-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    4NDC:70771-1419-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    5NDC:70771-1419-410 in 1 CARTON01/03/2019
    5NDC:70771-1419-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09045901/03/2019
    OLANZAPINE 
    olanzapine tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1420
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR) OLANZAPINE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeOVAL (ELLIPTICAL-SHAPED) Size12mm
    FlavorImprint Code ZF32
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1420-330 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    2NDC:70771-1420-660 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    3NDC:70771-1420-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    4NDC:70771-1420-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    5NDC:70771-1420-410 in 1 CARTON01/03/2019
    5NDC:70771-1420-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09045901/03/2019
    OLANZAPINE 
    olanzapine tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1421
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLANZAPINE (UNII: N7U69T4SZR) (OLANZAPINE - UNII:N7U69T4SZR) OLANZAPINE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeOVAL (ELLIPTICAL-SHAPED) Size14mm
    FlavorImprint Code ZF33
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1421-330 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    2NDC:70771-1421-660 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    3NDC:70771-1421-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    4NDC:70771-1421-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2019
    5NDC:70771-1421-410 in 1 CARTON01/03/2019
    5NDC:70771-1421-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09045901/03/2019
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(70771-1416, 70771-1417, 70771-1418, 70771-1419, 70771-1420, 70771-1421) , MANUFACTURE(70771-1416, 70771-1417, 70771-1418, 70771-1419, 70771-1420, 70771-1421)
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