cetirizine hydrochloride tablets, 10 mg (oval shape)

Generic: cetirizine hydrochloride

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

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride tablets, 10 mg (oval shape)
Generic Name cetirizine hydrochloride
Labeler marksans pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
MARKSANS PHARMA LIMITED

Identifiers & Regulatory

Product NDC 25000-160
Product ID 25000-160_cbb30ec0-aba7-4035-8f4a-a3e82b064857
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078933
Listing Expiration 2026-12-31
Marketing Start 2025-04-10

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 25000160
Hyphenated Format 25000-160

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, 10 mg (oval shape) (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA078933 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (25000-160-03) / 30 TABLET in 1 BOTTLE
  • 1000 TABLET in 1 BOTTLE (25000-160-14)
  • 1 BLISTER PACK in 1 CARTON (25000-160-81) / 14 TABLET in 1 BLISTER PACK
source: ndc

Packages (3)

25000-160-03 1 BOTTLE in 1 CARTON (25000-160-03) / 30 TABLET in 1 BOTTLE 25000-160-14 1000 TABLET in 1 BOTTLE (25000-160-14) 25000-160-81 1 BLISTER PACK in 1 CARTON (25000-160-81) / 14 TABLET in 1 BLISTER PACK

Ingredients (1)

cetirizine hydrochloride (10 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 (25000-160-03)  / 30 TABLET in 1 BOTTLE", "package_ndc": "25000-160-03", "marketing_start_date": "20250410"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (25000-160-14)", "package_ndc": "25000-160-14", "marketing_start_date": "20250410"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (25000-160-81)  / 14 TABLET in 1 BLISTER PACK", "package_ndc": "25000-160-81", "marketing_start_date": "20250410"}], "brand_name": "Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)", "product_id": "25000-160_cbb30ec0-aba7-4035-8f4a-a3e82b064857", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "25000-160", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "MARKSANS PHARMA LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078933", "marketing_category": "ANDA", "marketing_start_date": "20250410", "listing_expiration_date": "20261231"}