medline

Generic: cetirizine hcl

Labeler: medline industries, lp
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name medline
Generic Name cetirizine hcl
Labeler medline industries, lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Medline Industries, LP

Identifiers & Regulatory

Product NDC 53329-033
Product ID 53329-033_27d464c8-2b68-5598-e063-6394a90a7ad9
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209274
Listing Expiration 2026-12-31
Marketing Start 2020-05-01

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 53329033
Hyphenated Format 53329-033

Supplemental Identifiers

RxCUI
1014678
UPC
0193489019769
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 medline (source: ndc)
Generic Name cetirizine hcl (source: ndc)
Application Number ANDA209274 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (53329-033-33)
  • 90 TABLET in 1 BOTTLE (53329-033-38)
source: ndc

Packages (2)

53329-033-33 30 TABLET in 1 BOTTLE (53329-033-33) 53329-033-38 90 TABLET in 1 BOTTLE (53329-033-38)

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Medline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "27d464c8-2b68-5598-e063-6394a90a7ad9", "openfda": {"upc": ["0193489019769"], "unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["a75cd557-e19b-fdd4-e053-2a95a90a8097"], "manufacturer_name": ["Medline Industries, LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (53329-033-33)", "package_ndc": "53329-033-33", "marketing_start_date": "20200501"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (53329-033-38)", "package_ndc": "53329-033-38", "marketing_start_date": "20200501"}], "brand_name": "Medline", "product_id": "53329-033_27d464c8-2b68-5598-e063-6394a90a7ad9", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "53329-033", "generic_name": "cetirizine hcl", "labeler_name": "Medline Industries, LP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Medline", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA209274", "marketing_category": "ANDA", "marketing_start_date": "20200501", "listing_expiration_date": "20261231"}