Prescription Drug Information: ZIPRASIDONE MESYLATE (Page 6 of 6)

17 PATIENT COUNSELING INFORMATION

QTc Prolongation
Advise patients to inform their health care providers of the following: History of QT prolongation; recent acute myocardial infarction; uncompensated heart failure; prescription of other drugs that have demonstrated QT prolongation; risk for significant electrolyte abnormalities; and history of cardiac arrhythmia [see CONTRAINDICATIONS (4.1) and WARNINGS AND PRECAUTIONS (5.3)].

Instruct patients to report the onset of any conditions that put them at risk for significant electrolyte disturbances, hypokalemia in particular, including but not limited to the initiation of diuretic therapy or prolonged diarrhea. In addition, patients should be instructed to report symptoms such as dizziness, palpitations, or syncope to the prescriber [see WARNINGS AND PRECAUTIONS (5.3)].

Severe Cutaneous Adverse Reactions Instruct patients to report to their health care provider at the earliest onset any signs or symptoms that may be associated with Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or with severe cutaneous adverse reactions, such as Stevens-Johnson syndrome [see WARNINGS AND PRECAUTIONS (5.5)].

Distributor: Dr.Reddy’s Laboratories Inc.,

Princeton, NJ 08540

Made in India

Issued: 1019

PRINCIPAL DISPLAY PANEL — 51662-1564-2 VIAL AND POUCH LABELING

VIAL
(click image for full-size original)
POUCH
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 51662-1564-3 CASE AND SERIALIZATION LABELING

CASE
(click image for full-size original)

SERIALIZED
(click image for full-size original)
ZIPRASIDONE MESYLATE ziprasidone mesylate injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1564(NDC:43598-848)
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZIPRASIDONE MESYLATE (ZIPRASIDONE) ZIPRASIDONE 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BETADEX SULFOBUTYL ETHER SODIUM 294 mg in 1 mL
METHANESULFONIC ACID 4.7 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51662-1564-3 10 POUCH in 1 CASE contains a POUCH (51662-1564-2)
1 NDC:51662-1564-2 1 VIAL, SINGLE-DOSE in 1 POUCH This package is contained within the CASE (51662-1564-3) and contains a VIAL, SINGLE-DOSE
1 5 mL in 1 VIAL, SINGLE-DOSE This package is contained within a POUCH (51662-1564-2) and a CASE (51662-1564-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211908 07/17/2021
Labeler — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Registrant — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Establishment
Name Address ID/FEI Operations
HF Acquisition Co LLC, DBA HealthFirst 045657305 relabel (51662-1564)

Revised: 07/2021 HF Acquisition Co LLC, DBA HealthFirst

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