Label: CHLORPROMAZINE HYDROCHLORIDE tablet, film coated

  • NDC Code(s): 70771-1506-1, 70771-1506-2, 70771-1506-4, 70771-1507-1, view more
    70771-1507-2, 70771-1507-4, 70771-1508-1, 70771-1508-2, 70771-1508-4, 70771-1509-1, 70771-1509-2, 70771-1509-4, 70771-1510-1, 70771-1510-2, 70771-1510-4
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 7, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1506-1

    ChlorproMAZINE Hydrochloride Tablets, USP

    10 mg

    100 Tablets

    Rx only

    label

    NDC 70771-1507-1

    ChlorproMAZINE Hydrochloride Tablets, USP

    25 mg

    100 Tablets

    Rx only

    label

    NDC 70771-1508-1

    ChlorproMAZINE Hydrochloride Tablets, USP

    50 mg

    100 Tablets

    Rx only

    label

    NDC 70771-1509-1

    ChlorproMAZINE Hydrochloride Tablets, USP

    100 mg

    100 Tablets

    Rx only

    label

    NDC 70771-1510-1

    ChlorproMAZINE Hydrochloride Tablets, USP

    200 mg

    100 Tablets

    Rx only

    label
  • INGREDIENTS AND APPEARANCE
    CHLORPROMAZINE HYDROCHLORIDE 
    chlorpromazine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1506
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPROMAZINE HYDROCHLORIDE (UNII: 9WP59609J6) (CHLORPROMAZINE - UNII:U42B7VYA4P) CHLORPROMAZINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM SULFATE DIHYDRATE (UNII: 4846Q921YM)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 11;29
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1506-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2020
    2NDC:70771-1506-410 in 1 CARTON01/27/2020
    2NDC:70771-1506-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21336801/27/2020
    CHLORPROMAZINE HYDROCHLORIDE 
    chlorpromazine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1507
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPROMAZINE HYDROCHLORIDE (UNII: 9WP59609J6) (CHLORPROMAZINE - UNII:U42B7VYA4P) CHLORPROMAZINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM SULFATE DIHYDRATE (UNII: 4846Q921YM)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 11;30
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1507-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2020
    2NDC:70771-1507-410 in 1 CARTON01/27/2020
    2NDC:70771-1507-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21336801/27/2020
    CHLORPROMAZINE HYDROCHLORIDE 
    chlorpromazine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1508
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPROMAZINE HYDROCHLORIDE (UNII: 9WP59609J6) (CHLORPROMAZINE - UNII:U42B7VYA4P) CHLORPROMAZINE HYDROCHLORIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM SULFATE DIHYDRATE (UNII: 4846Q921YM)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 11;31
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1508-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2020
    2NDC:70771-1508-410 in 1 CARTON01/27/2020
    2NDC:70771-1508-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21336801/27/2020
    CHLORPROMAZINE HYDROCHLORIDE 
    chlorpromazine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1509
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPROMAZINE HYDROCHLORIDE (UNII: 9WP59609J6) (CHLORPROMAZINE - UNII:U42B7VYA4P) CHLORPROMAZINE HYDROCHLORIDE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM SULFATE DIHYDRATE (UNII: 4846Q921YM)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 11;32
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1509-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2020
    2NDC:70771-1509-410 in 1 CARTON01/27/2020
    2NDC:70771-1509-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21336801/27/2020
    CHLORPROMAZINE HYDROCHLORIDE 
    chlorpromazine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1510
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPROMAZINE HYDROCHLORIDE (UNII: 9WP59609J6) (CHLORPROMAZINE - UNII:U42B7VYA4P) CHLORPROMAZINE HYDROCHLORIDE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM SULFATE DIHYDRATE (UNII: 4846Q921YM)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code 11;33
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1510-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2020
    2NDC:70771-1510-410 in 1 CARTON01/27/2020
    2NDC:70771-1510-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21336801/27/2020
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (677605858)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited677605858ANALYSIS(70771-1506, 70771-1507, 70771-1508, 70771-1509, 70771-1510) , MANUFACTURE(70771-1506, 70771-1507, 70771-1508, 70771-1509, 70771-1510)