Haloperidol Lactate (Page 4 of 4)

HOW SUPPLIED

Haloperidol injection, USP (For Immediate Release) equivalent to 5 mg haloperidol per mL (as the lactate) is supplied as follows:

NDC 67457-426-12

1 mL (5 mg) vial, 25 vials per carton.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Do not freeze.

Manufactured for:
Mylan Institutional LLC
Morgantown, WV 26505 U.S.A.

Manufactured by:
Mylan Laboratories LimitedBangalore, India

JANUARY 2021

SAMPLE PACKAGE LABEL

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(click image for full-size original)

HALOPERIDOL LACTATE haloperidol injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52584-426(NDC:67457-426)
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
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52584-426-00 1 VIAL in 1 BAG contains a VIAL
1 1 mL in 1 VIAL This package is contained within the BAG (52584-426-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078347 10/13/2015
Labeler — General Injectables and Vaccines, Inc. (108250663)

Revised: 05/2022 General Injectables and Vaccines, Inc.

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