cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: sandoz inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler sandoz inc
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 5 mg/1

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-5283
Product ID 0781-5283_973d0d70-f69f-44b6-98f0-f436e63bd15a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078692
Listing Expiration 2026-12-31
Marketing Start 2008-02-14

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 07815283
Hyphenated Format 0781-5283

Supplemental Identifiers

RxCUI
1014643
UPC
0307815283643
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 ANDA078692 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0781-5283-64) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (0781-5283-06)
source: ndc

Packages (1)

0781-5283-64 30 BLISTER PACK in 1 CARTON (0781-5283-64) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (0781-5283-06)

Ingredients (1)

cetirizine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Cetirizine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "973d0d70-f69f-44b6-98f0-f436e63bd15a", "openfda": {"upc": ["0307815283643"], "unii": ["64O047KTOA"], "rxcui": ["1014643"], "spl_set_id": ["817d07cf-5e31-421f-9e95-943bae01f5b0"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0781-5283-64)  / 1 TABLET, CHEWABLE in 1 BLISTER PACK (0781-5283-06)", "package_ndc": "0781-5283-64", "marketing_start_date": "20080214"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "0781-5283_973d0d70-f69f-44b6-98f0-f436e63bd15a", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0781-5283", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Sandoz Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA078692", "marketing_category": "ANDA", "marketing_start_date": "20080214", "listing_expiration_date": "20261231"}