HALOPERIDOL DECANOATE injection
Haloperidol decanoate by
Drug Labeling and Warnings
Haloperidol decanoate by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
50 mg/mL Carton (3 vials per carton)
NDC: 70771-1851-9
Haloperidol Decanoate
Injection
50 mg/mL*
For Intramuscular Use Only
3 X 1 mL
Single-Dose Vials
Sterile
Rx only
250 mg/5 mL (50 mg/mL) Carton (1 vial per carton)
NDC: 70771-1852-1
Haloperidol Decanoate Injection
250 mg/5 mL*
(50 mg/mL)
For Intramuscular Use Only
5 mL
Multiple-Dose Vial
Sterile
Rx only
100 mg/mL Carton (1 vial per carton)
NDC: 70771-1853-1
Haloperidol Decanoate Injection
100 mg/mL*
For Intramuscular Use Only
1 mL
Single-Dose Vial
Sterile
Rx only
500 mg/5 mL (100 mg/mL) Carton (1 vial per carton)
NDC: 70771-1854-1
Haloperidol Decanoate Injection
500 mg/5 mL*
(100 mg/mL)
For Intramuscular Use Only
5 mL Multiple-Dose Vial
Sterile
Rx only
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INGREDIENTS AND APPEARANCE
HALOPERIDOL DECANOATE
haloperidol decanoate injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1851 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: 70771-1851-6 10 in 1 CARTON 11/14/2019 1 1 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product 2 NDC: 70771-1851-9 3 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: 70771-1852 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: 70771-1852-1 1 in 1 CARTON 11/14/2019 1 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC: 70771-1852-5 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: 70771-1853 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: 70771-1853-1 1 in 1 CARTON 11/14/2019 1 1 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product 2 NDC: 70771-1853-5 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: 70771-1854 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: 70771-1854-1 1 in 1 CARTON 11/14/2019 1 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC: 70771-1854-5 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 (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 873671928 MANUFACTURE(70771-1851, 70771-1852, 70771-1853, 70771-1854) , ANALYSIS(70771-1851, 70771-1852, 70771-1853, 70771-1854)
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