Label: HALOPERIDOL DECANOATE injection
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NDC Code(s):
72785-0004-1,
72785-0004-6,
72785-0004-9,
72785-0005-1, view more72785-0005-5, 72785-0006-1, 72785-0006-5, 72785-0007-1, 72785-0007-5
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated November 5, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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- SPL UNCLASSIFIED SECTION
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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
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
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
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
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
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
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
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
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
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
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
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
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INGREDIENTS AND APPEARANCE
HALOPERIDOL DECANOATE
haloperidol decanoate injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72785-0004 Route of Administration INTRAMUSCULAR Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HALOPERIDOL DECANOATE (UNII: AC20PJ4101) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength SESAME OIL (UNII: QX10HYY4QV) BENZYL ALCOHOL (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72785-0004-6 10 in 1 CARTON 11/14/2019 1 NDC:72785-0004-1 1 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product 2 NDC:72785-0004-9 3 in 1 CARTON 11/14/2019 2 NDC:72785-0004-1 1 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211180 11/14/2019 HALOPERIDOL DECANOATE
haloperidol decanoate injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72785-0005 Route of Administration INTRAMUSCULAR Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HALOPERIDOL DECANOATE (UNII: AC20PJ4101) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength SESAME OIL (UNII: QX10HYY4QV) BENZYL ALCOHOL (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72785-0005-1 1 in 1 CARTON 11/14/2019 1 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:72785-0005-5 5 in 1 CARTON 11/14/2019 2 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211180 11/14/2019 HALOPERIDOL DECANOATE
haloperidol decanoate injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72785-0006 Route of Administration INTRAMUSCULAR Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HALOPERIDOL DECANOATE (UNII: AC20PJ4101) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength SESAME OIL (UNII: QX10HYY4QV) BENZYL ALCOHOL (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72785-0006-1 1 in 1 CARTON 11/14/2019 1 1 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product 2 NDC:72785-0006-5 5 in 1 CARTON 11/14/2019 2 1 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211180 11/14/2019 HALOPERIDOL DECANOATE
haloperidol decanoate injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72785-0007 Route of Administration INTRAMUSCULAR Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HALOPERIDOL DECANOATE (UNII: AC20PJ4101) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength SESAME OIL (UNII: QX10HYY4QV) BENZYL ALCOHOL (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72785-0007-1 1 in 1 CARTON 11/14/2019 1 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:72785-0007-5 5 in 1 CARTON 11/14/2019 2 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211180 11/14/2019 Labeler - Zydus Lifesciences Limited (873671928) Registrant - Zydus Lifesciences Limited (873671928) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 873671928 ANALYSIS(72785-0004, 72785-0005, 72785-0006, 72785-0007) , MANUFACTURE(72785-0004, 72785-0005, 72785-0006, 72785-0007)