HALOPERIDOL DECANOATE- haloperidol decanoate injection 
Zydus Lifesciences Limited

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Haloperidol Decanoate Injection
For Intramuscular Injection Only

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

50 mg per mL carton label

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

250 mg per 5 mL carton label

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

100 mg per mL carton label

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

500 mg per 5 mL carton label
HALOPERIDOL DECANOATE 
haloperidol decanoate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1851
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:70771-1851-610 in 1 CARTON11/14/2019
11 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
2NDC:70771-1851-93 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:70771-1852
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:70771-1852-11 in 1 CARTON11/14/2019
15 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:70771-1852-55 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:70771-1853
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:70771-1853-11 in 1 CARTON11/14/2019
11 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
2NDC:70771-1853-55 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:70771-1854
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:70771-1854-11 in 1 CARTON11/14/2019
15 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC:70771-1854-55 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 - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited873671928MANUFACTURE(70771-1851, 70771-1852, 70771-1853, 70771-1854) , ANALYSIS(70771-1851, 70771-1852, 70771-1853, 70771-1854)

Revised: 9/2023
Document Id: 04562fb6-450e-4345-ac35-6bc8c940682a
Set id: d21796e5-9f29-4c0a-8eed-70aeb9f0e5e9
Version: 1
Effective Time: 20230901
 
Zydus Lifesciences Limited