crcle cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: innovus pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name crcle cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler innovus pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Innovus Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 57483-250
Product ID 57483-250_b1644d9c-353b-44bf-b3f9-9bd8b83976f2
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209274
Listing Expiration 2026-12-31
Marketing Start 2021-06-30

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 57483250
Hyphenated Format 57483-250

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 crcle cetirizine hydrochloride (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA209274 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 365 TABLET in 1 CONTAINER (57483-250-01)
source: ndc

Packages (1)

57483-250-01 365 TABLET in 1 CONTAINER (57483-250-01)

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Crcle Cetirizine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b1644d9c-353b-44bf-b3f9-9bd8b83976f2", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["640583b6-379d-4ad3-b00c-383377c54eed"], "manufacturer_name": ["Innovus Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "365 TABLET in 1 CONTAINER (57483-250-01)", "package_ndc": "57483-250-01", "marketing_start_date": "20230428"}], "brand_name": "Crcle Cetirizine Hydrochloride", "product_id": "57483-250_b1644d9c-353b-44bf-b3f9-9bd8b83976f2", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "57483-250", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Innovus Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Crcle Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA209274", "marketing_category": "ANDA", "marketing_start_date": "20210630", "listing_expiration_date": "20261231"}