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QUZYTTIR

These highlights do not include all the information needed to use QUZYTTIR™ safely and effectively. See full prescribing information for QUZYTTIR™.QUZYTTIR™ (cetirizine hydrochloride injection), for intravenous use Initial U.S. Approval: 1995

Approved
Approval ID

f33e859d-ebc9-4d4f-a57d-204c48760d20

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 25, 2022

Manufacturers
FDA

TerSera Therapeutics LLC

DUNS: 080226115

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Cetirizine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70720-100
Application NumberNDA211415
Product Classification
M
Marketing Category
C73594
G
Generic Name
Cetirizine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 27, 2020
FDA Product Classification

INGREDIENTS (5)

Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
cetirizine hydrochlorideActive
Quantity: 10 mg in 1 mL
Code: 64O047KTOA
Classification: ACTIB
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT

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QUZYTTIR - FDA Drug Approval Details