Haloperidol (Page 5 of 5)

VIAL LABEL — 1 mL

NDC 0143-9501 -01 Rx only
Haloperidol
Injection, USP
(For Immediate Release)
5 mg/mL
For Intramuscular
use ONLY1 mL Single Dose Vial

PLB955-WES.3
(click image for full-size original)

VIAL LABEL — 10 mL

NDC 0143-9502 -01 Rx only
Haloperidol
Injection, USP
(For Immediate Release)
50 mg per 10 mL
(5 mg/mL)
For Intramuscularuse ONLY

PLB956-WES.3
(click image for full-size original)

CARTON LABEL — 1 mL

NDC 0143-9501 -25 Rx only
Haloperidol
Injection, USP
(For Immediate Release)
5 mg/mL
For Intramuscular
use ONLY25 x 1 mL Single Dose Vials

PLB044-WES.4
(click image for full-size original)

CARTON — 10 mL

NDC 0143-9502 -01 Rx only
Haloperidol
Injection, USP
(For Immediate Release)
50 mg per 10 mL
(5 mg/mL)
For Intramuscular
use ONLY10 mL Sterile Multiple Dose Vial

PLB671-WES.4
(click image for full-size original)

SERIALIZATION IMAGE

Representative Carton Serialization Image

Representative Carton Serialization Image

HALOPERIDOL haloperidol lactate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9501
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HALOPERIDOL LACTATE (HALOPERIDOL) HALOPERIDOL 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN 1.8 mg in 1 mL
PROPYLPARABEN 0.2 mg in 1 mL
LACTIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9501-25 25 VIAL in 1 BOX contains a VIAL
1 1 mL in 1 VIAL This package is contained within the BOX (0143-9501-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075858 06/19/2001
HALOPERIDOL haloperidol lactate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9502
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HALOPERIDOL LACTATE (HALOPERIDOL) HALOPERIDOL 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN 1.8 mg in 1 mL
PROPYLPARABEN .2 mg in 1 mL
LACTIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9502-01 1 VIAL in 1 BOX contains a VIAL
1 10 mL in 1 VIAL This package is contained within the BOX (0143-9502-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075858 06/19/2001
Labeler — Hikma Pharmaceuticals USA Inc. (001230762)

Revised: 01/2021 Hikma Pharmaceuticals USA Inc.

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