quzyttir

Generic: cetirizine hydrochloride

Labeler: tersera therapeutics llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name quzyttir
Generic Name cetirizine hydrochloride
Labeler tersera therapeutics llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

cetirizine hydrochloride 10 mg/mL

Manufacturer
TerSera Therapeutics LLC

Identifiers & Regulatory

Product NDC 70720-100
Product ID 70720-100_32f69271-f228-41a9-8133-61cb47d73045
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211415
Listing Expiration 2027-12-31
Marketing Start 2019-11-13

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70720100
Hyphenated Format 70720-100

Supplemental Identifiers

UPC
0370720100107 0370720100251
UNII
64O047KTOA

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name quzyttir (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number NDA211415 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (70720-100-10) / 1 mL in 1 VIAL, GLASS (70720-100-01)
  • 25 VIAL, GLASS in 1 CARTON (70720-100-25) / 1 mL in 1 VIAL, GLASS (70720-100-01)
source: ndc

Packages (2)

70720-100-10 1 VIAL, GLASS in 1 CARTON (70720-100-10) / 1 mL in 1 VIAL, GLASS (70720-100-01) 70720-100-25 25 VIAL, GLASS in 1 CARTON (70720-100-25) / 1 mL in 1 VIAL, GLASS (70720-100-01)

Ingredients (1)

cetirizine hydrochloride (10 mg/mL)

Linked Drug Pages (1)

QUZYTTIR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "32f69271-f228-41a9-8133-61cb47d73045", "openfda": {"upc": ["0370720100107", "0370720100251"], "unii": ["64O047KTOA"], "spl_set_id": ["f33e859d-ebc9-4d4f-a57d-204c48760d20"], "manufacturer_name": ["TerSera Therapeutics LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (70720-100-10)  / 1 mL in 1 VIAL, GLASS (70720-100-01)", "package_ndc": "70720-100-10", "marketing_start_date": "20200402"}, {"sample": false, "description": "25 VIAL, GLASS in 1 CARTON (70720-100-25)  / 1 mL in 1 VIAL, GLASS (70720-100-01)", "package_ndc": "70720-100-25", "marketing_start_date": "20191113"}], "brand_name": "QUZYTTIR", "product_id": "70720-100_32f69271-f228-41a9-8133-61cb47d73045", "dosage_form": "INJECTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "70720-100", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "TerSera Therapeutics LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "QUZYTTIR", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "NDA211415", "marketing_category": "NDA", "marketing_start_date": "20191113", "listing_expiration_date": "20271231"}