Haloperidol Decanoate (Page 6 of 6)

PRINCIPAL DISPLAY PANEL – Haloperidol Decanoate Injection 50 mg per mL Container Label

NDC 71288-502 -01

Rx Only

Haloperidol Decanoate Injection

50 mg per mL*

For Intramuscular Use Only

1 mL Single-Dose Vial

50 mg per mL vial label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – Haloperidol Decanoate Injection 50 mg per mL Carton

NDC 71288-502 -02

Rx Only

Haloperidol Decanoate Injection

50 mg per mL*

For Intramuscular Use Only

10 x 1 mL Single-Dose Vials

50 mg per mL carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – Haloperidol Decanoate Injection 100 mg per mL Container Label

NDC 71288-503 -01

Rx Only

Haloperidol Decanoate Injection

100 mg per mL*

For Intramuscular Use Only

1 mL Single-Dose Vial

100 mg per mL vial label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – Haloperidol Decanoate Injection 100 mg per mL Carton

NDC 71288-503 -02

Rx Only

Haloperidol Decanoate Injection

100 mg per mL*

For Intramuscular Use Only

10 x 1 mL Single-Dose Vials

100 mg per mL carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – Haloperidol Decanoate Injection 500 mg per 5 mL Container Label

NDC 71288-504 -05

Rx Only

Haloperidol Decanoate Injection

500 mg per 5 mL*

(100 mg per mL)

For Intramuscular Use Only

5 mL Multi-Dose Vial

500 mg per 5 mL vial label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – Haloperidol Decanoate Injection 500 mg per 5 mL Carton

NDC 71288-504 -05

Rx Only

Haloperidol Decanoate Injection

500 mg per 5 mL*

(100 mg per mL)

For Intramuscular Use Only

1 x 5 mL Multi-Dose Vial

500 mg per 5 mL carton
(click image for full-size original)
HALOPERIDOL DECANOATE
haloperidol decanoate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71288-502
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
haloperidol decanoate (haloperidol) haloperidol 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
benzyl alcohol
sesame oil
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71288-502-02 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (71288-502-01)
1 NDC:71288-502-01 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (71288-502-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214507 07/26/2021
HALOPERIDOL DECANOATE
haloperidol decanoate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71288-503
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
haloperidol decanoate (haloperidol) haloperidol 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
benzyl alcohol
sesame oil
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71288-503-02 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (71288-503-01)
1 NDC:71288-503-01 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (71288-503-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214507 07/26/2021
HALOPERIDOL DECANOATE
haloperidol decanoate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71288-504
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
haloperidol decanoate (haloperidol) haloperidol 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
benzyl alcohol
sesame oil
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71288-504-05 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (71288-504-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214507 07/26/2021
Labeler — Meitheal Pharmaceuticals Inc. (080548348)

Revised: 07/2021 Meitheal Pharmaceuticals Inc.

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