cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: quagen pharmaceuticals llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler quagen pharmaceuticals llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 1 mg/mL

Manufacturer
QUAGEN PHARMACEUTICALS LLC

Identifiers & Regulatory

Product NDC 70752-104
Product ID 70752-104_eb119bad-6e21-4378-a556-41b1b790d84c
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA212266
Listing Expiration 2026-12-31
Marketing Start 2022-10-15

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 70752104
Hyphenated Format 70752-104

Supplemental Identifiers

RxCUI
1014673
UPC
0370752104067
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 cetirizine hydrochloride (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA212266 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (70752-104-06) / 118 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

70752-104-06 1 BOTTLE, PLASTIC in 1 CARTON (70752-104-06) / 118 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

cetirizine hydrochloride (1 mg/mL)

Linked Drug Pages (1)

CETIRIZINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "eb119bad-6e21-4378-a556-41b1b790d84c", "openfda": {"upc": ["0370752104067"], "unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["9163cd2e-0be7-4009-b905-729014773d6e"], "manufacturer_name": ["QUAGEN PHARMACEUTICALS LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (70752-104-06)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "70752-104-06", "marketing_start_date": "20221015"}], "brand_name": "CETIRIZINE HYDROCHLORIDE", "product_id": "70752-104_eb119bad-6e21-4378-a556-41b1b790d84c", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "70752-104", "generic_name": "CETIRIZINE HYDROCHLORIDE", "labeler_name": "QUAGEN PHARMACEUTICALS LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CETIRIZINE HYDROCHLORIDE", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA212266", "marketing_category": "ANDA", "marketing_start_date": "20221015", "listing_expiration_date": "20261231"}