FDA.reportPublic FDA data

QUZYTTIR

Product NDC
70720-100
11-digit product format
707200100
Labeler code
70720
Product ID
70720-100_32f69271-f228-41a9-8133-61cb47d73045
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
TerSera Therapeutics LLC
Application
NDA211415
Marketing category
NDA
Marketing start
2019-11-13
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
QUZYTTIR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui2261746, 2261754

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70720-100-01QUZYTTIR1 mL in 1 VIAL, GLASSINJECTION18
70720-100-10QUZYTTIR1 in 1 CARTONINJECTION18
70720-100-25QUZYTTIR25 in 1 CARTONINJECTION258

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70720-100-01ML - Milliliter70720-100ee4a9b09-4331-4c5c-bb89-4a1f56fa9faa12019-12-10
70720-100-10ML - Milliliter70720-100101d0bd6-4059-4bbe-880a-10938ad3d73312020-06-05
70720-100-25ML - Milliliter70720-1007047f5c4-027a-4798-a4d1-8d9fce348ce012019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70720-100QUZYTTIR (CETIRIZINE HYDROCHLORIDE) INJECTION [TERSERA THERAPEUTICS LLC]4Current NDC, Legacy NDC, 3 package rows20221027_f33e859d-ebc9-4d4f-a57d-204c48760d20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2261746cetirizine hydrochloride 10 MG in 1 ML InjectionPSNf33e859d-ebc9-4d4f-a57d-204c48760d208
2261754QUZYTTIR 10 MG in 1 ML InjectionPSNf33e859d-ebc9-4d4f-a57d-204c48760d208
22617541 ML cetirizine hydrochloride 10 MG/ML Injection [Quzyttir]SBDf33e859d-ebc9-4d4f-a57d-204c48760d208
22617461 ML cetirizine hydrochloride 10 MG/ML InjectionSCDf33e859d-ebc9-4d4f-a57d-204c48760d208
2261746cetirizine hydrochloride 10 MG per 1 ML InjectionSYf33e859d-ebc9-4d4f-a57d-204c48760d208
2261754Quzyttir 10 MG per 1 ML InjectionSYf33e859d-ebc9-4d4f-a57d-204c48760d208

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70720-100-01707200100011 mL in 1 VIAL, GLASS1 mlHistorical
70720-100-10707200100101 VIAL, GLASS in 1 CARTON (70720-100-10) / 1 mL in 1 VIAL, GLASS (70720-100-01) 2020-04-020000-00-00NoNoCurrent
70720-100-257072001002525 VIAL, GLASS in 1 CARTON (70720-100-25) / 1 mL in 1 VIAL, GLASS (70720-100-01) 2019-11-130000-00-00NoNoCurrent