cetirizine

Generic: cetirizine hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine
Generic Name cetirizine hydrochloride
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6717
Product ID 0904-6717_cdf7d985-c5aa-4002-a152-58fe4d6ba6e2
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078336
Listing Expiration 2027-12-31
Marketing Start 2018-06-29

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 09046717
Hyphenated Format 0904-6717

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 (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA078336 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (0904-6717-40)
  • 14 BLISTER PACK in 1 CARTON (0904-6717-41) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (0904-6717-43) / 45 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0904-6717-46) / 30 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0904-6717-60) / 100 TABLET, FILM COATED in 1 BOTTLE
  • 100 BLISTER PACK in 1 CARTON (0904-6717-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (0904-6717-72) / 300 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0904-6717-86) / 90 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (8)

0904-6717-40 500 TABLET, FILM COATED in 1 BOTTLE (0904-6717-40) 0904-6717-41 14 BLISTER PACK in 1 CARTON (0904-6717-41) / 1 TABLET, FILM COATED in 1 BLISTER PACK 0904-6717-43 1 BOTTLE in 1 CARTON (0904-6717-43) / 45 TABLET, FILM COATED in 1 BOTTLE 0904-6717-46 1 BOTTLE in 1 CARTON (0904-6717-46) / 30 TABLET, FILM COATED in 1 BOTTLE 0904-6717-60 1 BOTTLE in 1 CARTON (0904-6717-60) / 100 TABLET, FILM COATED in 1 BOTTLE 0904-6717-61 100 BLISTER PACK in 1 CARTON (0904-6717-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK 0904-6717-72 1 BOTTLE in 1 CARTON (0904-6717-72) / 300 TABLET, FILM COATED in 1 BOTTLE 0904-6717-86 1 BOTTLE in 1 CARTON (0904-6717-86) / 90 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cdf7d985-c5aa-4002-a152-58fe4d6ba6e2", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["a5be7921-c1cb-4b9f-9f4a-1c4b68b2b8a3"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (0904-6717-40)", "package_ndc": "0904-6717-40", "marketing_start_date": "20180703"}, {"sample": false, "description": "14 BLISTER PACK in 1 CARTON (0904-6717-41)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6717-41", "marketing_start_date": "20180629"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0904-6717-43)  / 45 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0904-6717-43", "marketing_start_date": "20180703"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0904-6717-46)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0904-6717-46", "marketing_start_date": "20180703"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0904-6717-60)  / 100 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0904-6717-60", "marketing_start_date": "20180703"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6717-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6717-61", "marketing_end_date": "20260630", "marketing_start_date": "20180629"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0904-6717-72)  / 300 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0904-6717-72", "marketing_start_date": "20180703"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0904-6717-86)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0904-6717-86", "marketing_start_date": "20180703"}], "brand_name": "Cetirizine", "product_id": "0904-6717_cdf7d985-c5aa-4002-a152-58fe4d6ba6e2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0904-6717", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078336", "marketing_category": "ANDA", "marketing_start_date": "20180629", "listing_expiration_date": "20271231"}