cetirizine hydrochloride (70677-1007)

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride

Generic Name cetirizine hydrochloride tablets

Labeler strategic sourcing services llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer

Strategic Sourcing Services LLC

Identifiers & Regulatory

Product NDC 70677-1007

Product ID 70677-1007_b13a3e2a-c087-727c-8d9e-90faa85292e6

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA078343

Marketing Start 2022-05-12

Marketing End 2027-02-28

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 706771007

Hyphenated Format 70677-1007

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 tablets (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 (70677-1007-1) / 30 TABLET, FILM COATED in 1 BOTTLE
1 BOTTLE in 1 CARTON (70677-1007-2) / 60 TABLET, FILM COATED in 1 BOTTLE
1 BOTTLE in 1 CARTON (70677-1007-3) / 90 TABLET, FILM COATED in 1 BOTTLE
1 BOTTLE in 1 CARTON (70677-1007-4) / 300 TABLET, FILM COATED in 1 BOTTLE

source: ndc

Packages (4)

70677-1007-1 1 BOTTLE in 1 CARTON (70677-1007-1) / 30 TABLET, FILM COATED in 1 BOTTLE 70677-1007-2 1 BOTTLE in 1 CARTON (70677-1007-2) / 60 TABLET, FILM COATED in 1 BOTTLE 70677-1007-3 1 BOTTLE in 1 CARTON (70677-1007-3) / 90 TABLET, FILM COATED in 1 BOTTLE 70677-1007-4 1 BOTTLE in 1 CARTON (70677-1007-4) / 300 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": "b13a3e2a-c087-727c-8d9e-90faa85292e6", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["52b70885-f623-b1c8-29c6-584bff46ed45"], "manufacturer_name": ["Strategic Sourcing Services LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70677-1007-1)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "70677-1007-1", "marketing_end_date": "20260731", "marketing_start_date": "20230505"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (70677-1007-2)  / 60 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "70677-1007-2", "marketing_end_date": "20270228", "marketing_start_date": "20230505"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (70677-1007-3)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "70677-1007-3", "marketing_end_date": "20270131", "marketing_start_date": "20230505"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (70677-1007-4)  / 300 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "70677-1007-4", "marketing_end_date": "20270228", "marketing_start_date": "20230505"}], "brand_name": "cetirizine hydrochloride", "product_id": "70677-1007_b13a3e2a-c087-727c-8d9e-90faa85292e6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "70677-1007", "generic_name": "Cetirizine Hydrochloride Tablets", "labeler_name": "Strategic Sourcing Services LLC", "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_end_date": "20270228", "marketing_start_date": "20220512"}