members mark childrens cetirizine (68196-475)

Drug Facts

Product Profile

Brand Name members mark childrens cetirizine

Generic Name cetirizine hydrochloride

Labeler sam's west inc

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

cetirizine hydrochloride 5 mg/5mL

Manufacturer

Sam's West Inc

Identifiers & Regulatory

Product NDC 68196-475

Product ID 68196-475_c1765b31-cc97-4f6e-bb57-d90f16b73a15

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA204226

Listing Expiration 2026-12-31

Marketing Start 2024-09-23

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 68196475

Hyphenated Format 68196-475

Supplemental Identifiers

RxCUI

1014673

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 members mark childrens cetirizine (source: ndc)

Generic Name cetirizine hydrochloride (source: ndc)

Application Number ANDA204226 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/5mL

source: ndc

Packaging

2 BOTTLE in 1 CARTON (68196-475-43) / 240 mL in 1 BOTTLE (68196-475-34)

source: ndc

Packages (1)

68196-475-43 2 BOTTLE in 1 CARTON (68196-475-43) / 240 mL in 1 BOTTLE (68196-475-34)

Ingredients (1)

cetirizine hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

Members Mark Childrens Cetirizine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "c1765b31-cc97-4f6e-bb57-d90f16b73a15", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["9c6e7a8b-f8ad-4f6b-abb1-5cde86b75c7d"], "manufacturer_name": ["Sam's West Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE in 1 CARTON (68196-475-43)  / 240 mL in 1 BOTTLE (68196-475-34)", "package_ndc": "68196-475-43", "marketing_start_date": "20240923"}], "brand_name": "Members Mark Childrens Cetirizine", "product_id": "68196-475_c1765b31-cc97-4f6e-bb57-d90f16b73a15", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68196-475", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Sam's West Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Members Mark Childrens Cetirizine", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "ANDA204226", "marketing_category": "ANDA", "marketing_start_date": "20240923", "listing_expiration_date": "20261231"}