cetirizine hydrochloride 10 mg

Generic: cetirizine hydrochloride

Labeler: twin med, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride 10 mg
Generic Name cetirizine hydrochloride
Labeler twin med, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
TWIN MED, LLC

Identifiers & Regulatory

Product NDC 55681-302
Product ID 55681-302_0e12b3c6-357a-b0dc-e063-6394a90a8ea4
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209274
Listing Expiration 2026-12-31
Marketing Start 2022-03-02

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 55681302
Hyphenated Format 55681-302

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 10 mg (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
  • 300 TABLET in 1 BOTTLE (55681-302-03)
source: ndc

Packages (1)

55681-302-03 300 TABLET in 1 BOTTLE (55681-302-03)

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

CETIRIZINE HYDROCHLORIDE 10 MG ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0e12b3c6-357a-b0dc-e063-6394a90a8ea4", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["d9437d88-da59-5567-e053-2995a90a362b"], "manufacturer_name": ["TWIN MED, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "300 TABLET in 1 BOTTLE (55681-302-03)", "package_ndc": "55681-302-03", "marketing_start_date": "20220302"}], "brand_name": "CETIRIZINE HYDROCHLORIDE 10 MG", "product_id": "55681-302_0e12b3c6-357a-b0dc-e063-6394a90a8ea4", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "55681-302", "generic_name": "CETIRIZINE HYDROCHLORIDE", "labeler_name": "TWIN MED, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CETIRIZINE HYDROCHLORIDE", "brand_name_suffix": "10 MG", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA209274", "marketing_category": "ANDA", "marketing_start_date": "20220302", "listing_expiration_date": "20261231"}