cetirizine hydrochloride tablets, 5 mg

Generic: cetirizine hydrochloride

Labeler: marksans pharma limited
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride tablets, 5 mg
Generic Name cetirizine hydrochloride
Labeler marksans pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 5 mg/1

Manufacturer
MARKSANS PHARMA LIMITED

Identifiers & Regulatory

Product NDC 25000-219
Product ID 25000-219_cbb30ec0-aba7-4035-8f4a-a3e82b064857
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078933
Listing Expiration 2026-12-31
Marketing Start 2022-01-13

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 25000219
Hyphenated Format 25000-219

Supplemental Identifiers

RxCUI
1014676 1014678
UPC
0325000160814 0325000219147 0325000219086 0325000160036 0325000160142 0325000220785 0325000220037 0325000220082 0325000219031 0325000220143 0325000220815
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 tablets, 5 mg (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA078933 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (25000-219-03) / 30 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (25000-219-08) / 100 TABLET in 1 BOTTLE
  • 1000 TABLET in 1 BOTTLE (25000-219-14)
source: ndc

Packages (3)

25000-219-03 1 BOTTLE in 1 CARTON (25000-219-03) / 30 TABLET in 1 BOTTLE 25000-219-08 1 BOTTLE in 1 CARTON (25000-219-08) / 100 TABLET in 1 BOTTLE 25000-219-14 1000 TABLET in 1 BOTTLE (25000-219-14)

Ingredients (1)

cetirizine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape), Cetirizine Hydrochloride Tablets, 5 mg, Cetirizine Hydrochloride Tablets, 10 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cbb30ec0-aba7-4035-8f4a-a3e82b064857", "openfda": {"upc": ["0325000160814", "0325000219147", "0325000219086", "0325000160036", "0325000160142", "0325000220785", "0325000220037", "0325000220082", "0325000219031", "0325000220143", "0325000220815"], "unii": ["64O047KTOA"], "rxcui": ["1014676", "1014678"], "spl_set_id": ["652b0c65-a3f2-4454-9cf2-51a3389282cc"], "manufacturer_name": ["MARKSANS PHARMA LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (25000-219-03)  / 30 TABLET in 1 BOTTLE", "package_ndc": "25000-219-03", "marketing_start_date": "20220113"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (25000-219-08)  / 100 TABLET in 1 BOTTLE", "package_ndc": "25000-219-08", "marketing_start_date": "20220113"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (25000-219-14)", "package_ndc": "25000-219-14", "marketing_start_date": "20220113"}], "brand_name": "Cetirizine Hydrochloride Tablets, 5 mg", "product_id": "25000-219_cbb30ec0-aba7-4035-8f4a-a3e82b064857", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "25000-219", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "MARKSANS PHARMA LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride Tablets, 5 mg", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA078933", "marketing_category": "ANDA", "marketing_start_date": "20220113", "listing_expiration_date": "20261231"}