cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 55289-995
Product ID 55289-995_419b90dc-3863-d390-e063-6394a90adcbb
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077498
Listing Expiration 2026-12-31
Marketing Start 2007-12-27

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 55289995
Hyphenated Format 55289-995

Supplemental Identifiers

RxCUI
1014678
UNII
64O047KTOA

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 ANDA077498 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 7 TABLET in 1 BOTTLE, PLASTIC (55289-995-07)
  • 10 TABLET in 1 BOTTLE, PLASTIC (55289-995-10)
  • 30 TABLET in 1 BOTTLE, PLASTIC (55289-995-30)
  • 90 TABLET in 1 BOTTLE, PLASTIC (55289-995-90)
source: ndc

Packages (4)

55289-995-07 7 TABLET in 1 BOTTLE, PLASTIC (55289-995-07) 55289-995-10 10 TABLET in 1 BOTTLE, PLASTIC (55289-995-10) 55289-995-30 30 TABLET in 1 BOTTLE, PLASTIC (55289-995-30) 55289-995-90 90 TABLET in 1 BOTTLE, PLASTIC (55289-995-90)

Ingredients (1)

cetirizine hydrochloride (10 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": "419b90dc-3863-d390-e063-6394a90adcbb", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["a7da81e1-8865-45c9-83c7-32fb8032ca2e"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "7 TABLET in 1 BOTTLE, PLASTIC (55289-995-07)", "package_ndc": "55289-995-07", "marketing_start_date": "20220308"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (55289-995-10)", "package_ndc": "55289-995-10", "marketing_start_date": "20220809"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (55289-995-30)", "package_ndc": "55289-995-30", "marketing_start_date": "20180426"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (55289-995-90)", "package_ndc": "55289-995-90", "marketing_start_date": "20180426"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "55289-995_419b90dc-3863-d390-e063-6394a90adcbb", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "55289-995", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA077498", "marketing_category": "ANDA", "marketing_start_date": "20071227", "listing_expiration_date": "20261231"}