cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 5 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-343
Product ID 47335-343_2ffbb45f-ed2b-4f1a-bc4c-1e8c1ddcbfd3
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090142
Listing Expiration 2026-12-31
Marketing Start 2011-09-09

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 47335343
Hyphenated Format 47335-343

Supplemental Identifiers

RxCUI
1014643 1014674
UPC
0347335344837 0347335343830
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 ANDA090142 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, CHEWABLE in 1 BOTTLE (47335-343-83)
  • 100 TABLET, CHEWABLE in 1 BOTTLE (47335-343-88)
source: ndc

Packages (2)

47335-343-83 30 TABLET, CHEWABLE in 1 BOTTLE (47335-343-83) 47335-343-88 100 TABLET, CHEWABLE in 1 BOTTLE (47335-343-88)

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": "2ffbb45f-ed2b-4f1a-bc4c-1e8c1ddcbfd3", "openfda": {"upc": ["0347335344837", "0347335343830"], "unii": ["64O047KTOA"], "rxcui": ["1014643", "1014674"], "spl_set_id": ["a4758152-97dd-4a27-b4d9-11178654b93e"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, CHEWABLE in 1 BOTTLE (47335-343-83)", "package_ndc": "47335-343-83", "marketing_start_date": "20110909"}, {"sample": false, "description": "100 TABLET, CHEWABLE in 1 BOTTLE (47335-343-88)", "package_ndc": "47335-343-88", "marketing_start_date": "20110909"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "47335-343_2ffbb45f-ed2b-4f1a-bc4c-1e8c1ddcbfd3", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "47335-343", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA090142", "marketing_category": "ANDA", "marketing_start_date": "20110909", "listing_expiration_date": "20261231"}