Label: HALOPERIDOL DECANOATE injection

  • NDC Code(s): 72785-0004-1, 72785-0004-6, 72785-0004-9, 72785-0005-1, view more
    72785-0005-5, 72785-0006-1, 72785-0006-5, 72785-0007-1, 72785-0007-5
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 28, 2020

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

  • SPL UNCLASSIFIED SECTION

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - 50 mg/mL Vial Label

    NDC 72785-0004-1

    Haloperidol

    Decanoate

    Injection

    50 mg/mL*

    For Intramuscular Use Only

    1 mL Single-Dose Vial

    Sterile

    Rx only

    zydus pharmaceuticals

    Haloperidol decanoate Injection, 50 mg per mL  Vial Label

    PRINCIPAL DISPLAY PANEL - 250 mg/5 mL (50 mg/mL) Vial Label

    NDC 72785-0005-1

    Haloperidol

    Decanoate Injection

    250 mg/5 mL*

    (50 mg/mL)

    For Intramuscular Use Only

    5 mL Multiple-Dose Vial

    Sterile

    Rx only

    zydus pharmaceuticals

    Haloperidol decanoate Injection, 250 mg per 5 mL (50 mg per mL) Vial Label

    PRINCIPAL DISPLAY PANEL - 100 mg/mL Vial Label

    NDC 72785-0006-1

    Haloperidol

    Decanoate

    Injection

    100 mg/mL*

    For Intramuscular Use Only

    1 mL Single-Dose Vial

    Sterile

    Rx only

    zydus pharmaceuticals

    Haloperidol decanoate Injection, 100 mg per mL Vial Label

    PRINCIPAL DISPLAY PANEL - 500 mg/5 mL (100 mg/mL) Vial Label

    NDC 72785-0007-1

    Haloperidol

    Decanoate Injection

    500 mg/5 mL*

    (100 mg/mL)

    For Intramuscular Use Only

    5 mL Multiple-Dose Vial

    Sterile

    Rx only

    zydus pharmaceuticals

    Haloperidol decanoate Injection, 500 mg per 5 mL (100 mg per mL) Vial Label

    PRINCIPAL DISPLAY PANEL –

    50 mg/mL Carton (3 vials per carton)

    NDC 72785-0004-9

    Haloperidol Decanoate

    Injection

    50 mg/mL*

    For Intramuscular Use Only

    3 X 1 mL

    Single-Dose Vials

    Sterile

    Rx only

    zydus pharmaceuticals

    Haloperidol decanoate Injection, 50 mg per mL  Carton (3 Vials per carton)

    PRINCIPAL DISPLAY PANEL –

    50 mg/mL Carton (10 vials per carton)

    NDC 72785-0004-6

    Haloperidol Decanoate

    Injection

    50 mg/mL*

    For Intramuscular Use Only

    10 X 1 mL Single-Dose Vials

    Sterile

    Rx only

    zydus pharmaceuticals

    Haloperidol decanoate Injection, 50 mg per mL  Carton (10 Vials per carton)

    PRINCIPAL DISPLAY PANEL –

    250 mg/5 mL (50 mg/mL) Carton (1 vial per carton)

    NDC 72785-0005-1

    Haloperidol

    Decanoate

    Injection

    250 mg/5 mL*

    (50 mg/mL)

    For Intramuscular Use Only

    5 mL

    Multiple-Dose Vial

    Sterile

    Rx only

    zydus pharmaceuticals

    Haloperidol decanoate Injection, 250 mg per 5 mL Carton (1 Vial per carton)

    PRINCIPAL DISPLAY PANEL –

    250 mg/5 mL (50 mg/mL) Carton (5 vials per carton)

    NDC 72785-0005-5

    Haloperidol Decanoate Injection

    250 mg/5 mL*

    (50 mg/mL)

    For Intramuscular Use Only

    5 X 5 mL Multiple-Dose Vials

    Sterile

    Rx only

    zydus pharmaceuticals

    Haloperidol decanoate Injection, 250 mg per 5 mL Carton (5 Vials per carton)

    PRINCIPAL DISPLAY PANEL –

    100 mg/mL Carton (1 vial per carton)

    NDC 72785-0006-1

    Haloperidol

    Decanoate

    Injection

    100 mg/mL*

    For Intramuscular Use Only

    1 mL

    Single-Dose Vial

    Sterile

    Rx only

    zydus pharmaceuticals

    Haloperidol decanoate Injection, 100 mg per mL Carton (1 Vial per carton)

    PRINCIPAL DISPLAY PANEL –

    100 mg/mL Carton (5 vials per carton)

    NDC 72785-0006-5

    Haloperidol Decanoate Injection

    100 mg/mL*

    For Intramuscular Use Only

    5 X 1 mL Single-Dose Vials

    Sterile

    Rx only

    zydus pharmaceuticals

    Haloperidol decanoate Injection, 100 mg per mL Carton (5 Vials per carton)

    PRINCIPAL DISPLAY PANEL –

    500 mg/5 mL (100 mg/mL) Carton (1 vial per carton)

    NDC 72785-0007-1

    Haloperidol

    Decanoate

    Injection

    500 mg/5 mL*

    (100 mg/mL)

    For Intramuscular Use Only

    5 mL Multiple-Dose Vial

    Sterile

    Rx only

    zydus pharmaceuticals

    Haloperidol decanoate Injection, 500 mg per 5 mL Carton (1 Vial per carton)

    PRINCIPAL DISPLAY PANEL –

    500 mg/5 mL (100 mg/mL) Carton (5 vials per carton)

    NDC 72785-0007-5

    Haloperidol Decanoate Injection

    500 mg/5 mL*

    (100 mg/mL)

    For Intramuscular Use Only

    5 X 5 mL Multiple-Dose Vials

    Sterile

    Rx only

    zydus pharmaceuticals

    Haloperidol decanoate Injection, 500 mg per 5 mL Carton (5 Vials per carton)
  • INGREDIENTS AND APPEARANCE
    HALOPERIDOL DECANOATE 
    haloperidol decanoate injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72785-0004
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HALOPERIDOL DECANOATE (UNII: AC20PJ4101) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SESAME OIL (UNII: QX10HYY4QV)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72785-0004-610 in 1 CARTON11/14/2019
    1NDC:72785-0004-11 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    2NDC:72785-0004-93 in 1 CARTON11/14/2019
    2NDC:72785-0004-11 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21118011/14/2019
    HALOPERIDOL DECANOATE 
    haloperidol decanoate injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72785-0005
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HALOPERIDOL DECANOATE (UNII: AC20PJ4101) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SESAME OIL (UNII: QX10HYY4QV)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72785-0005-11 in 1 CARTON11/14/2019
    15 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    2NDC:72785-0005-55 in 1 CARTON11/14/2019
    25 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21118011/14/2019
    HALOPERIDOL DECANOATE 
    haloperidol decanoate injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72785-0006
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HALOPERIDOL DECANOATE (UNII: AC20PJ4101) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SESAME OIL (UNII: QX10HYY4QV)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72785-0006-11 in 1 CARTON11/14/2019
    11 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    2NDC:72785-0006-55 in 1 CARTON11/14/2019
    21 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21118011/14/2019
    HALOPERIDOL DECANOATE 
    haloperidol decanoate injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72785-0007
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HALOPERIDOL DECANOATE (UNII: AC20PJ4101) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SESAME OIL (UNII: QX10HYY4QV)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72785-0007-11 in 1 CARTON11/14/2019
    15 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    2NDC:72785-0007-55 in 1 CARTON11/14/2019
    25 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21118011/14/2019
    Labeler - Cadila Healthcare Limited (873671928)
    Registrant - Cadila Healthcare Limited (873671928)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited873671928ANALYSIS(72785-0004, 72785-0005, 72785-0006, 72785-0007) , MANUFACTURE(72785-0004, 72785-0005, 72785-0006, 72785-0007)