cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: dr.reddy's laboratories limited
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler dr.reddy's laboratories limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Dr.Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-351
Product ID 55111-351_000d3a47-3836-b678-9487-2bbc518cd57f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078343
Listing Expiration 2026-12-31
Marketing Start 2008-01-15

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 55111351
Hyphenated Format 55111-351

Supplemental Identifiers

RxCUI
1014678
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 ANDA078343 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (55111-351-04) / 120 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (55111-351-30) / 30 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (55111-351-45) / 45 TABLET, FILM COATED in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (55111-351-47) / 175 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (55111-351-51) / 75 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (55111-351-60) / 60 TABLET, FILM COATED in 1 BOTTLE
  • 2 BLISTER PACK in 1 CARTON (55111-351-74) / 7 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (55111-351-90) / 90 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (8)

55111-351-04 1 BOTTLE in 1 CARTON (55111-351-04) / 120 TABLET, FILM COATED in 1 BOTTLE 55111-351-30 1 BOTTLE in 1 CARTON (55111-351-30) / 30 TABLET, FILM COATED in 1 BOTTLE 55111-351-45 1 BOTTLE in 1 CARTON (55111-351-45) / 45 TABLET, FILM COATED in 1 BOTTLE 55111-351-47 2 BOTTLE in 1 CARTON (55111-351-47) / 175 TABLET, FILM COATED in 1 BOTTLE 55111-351-51 1 BOTTLE in 1 CARTON (55111-351-51) / 75 TABLET, FILM COATED in 1 BOTTLE 55111-351-60 1 BOTTLE in 1 CARTON (55111-351-60) / 60 TABLET, FILM COATED in 1 BOTTLE 55111-351-74 2 BLISTER PACK in 1 CARTON (55111-351-74) / 7 TABLET, FILM COATED in 1 BLISTER PACK 55111-351-90 1 BOTTLE in 1 CARTON (55111-351-90) / 90 TABLET, FILM COATED in 1 BOTTLE

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": "000d3a47-3836-b678-9487-2bbc518cd57f", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["de152651-bfcd-856a-8329-a2ac93a376bc"], "manufacturer_name": ["Dr.Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-351-04)  / 120 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "55111-351-04", "marketing_start_date": "20080115"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-351-30)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "55111-351-30", "marketing_start_date": "20080115"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-351-45)  / 45 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "55111-351-45", "marketing_start_date": "20080115"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (55111-351-47)  / 175 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "55111-351-47", "marketing_start_date": "20080115"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-351-51)  / 75 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "55111-351-51", "marketing_start_date": "20080115"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-351-60)  / 60 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "55111-351-60", "marketing_start_date": "20080115"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (55111-351-74)  / 7 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "55111-351-74", "marketing_start_date": "20080115"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-351-90)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "55111-351-90", "marketing_start_date": "20080115"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "55111-351_000d3a47-3836-b678-9487-2bbc518cd57f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "55111-351", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Dr.Reddy's Laboratories Limited", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078343", "marketing_category": "ANDA", "marketing_start_date": "20080115", "listing_expiration_date": "20261231"}