members mark allergy relief

Generic: cetirizine hydrochloride

Labeler: sam's west inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name members mark allergy relief
Generic Name cetirizine hydrochloride
Labeler sam's west inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Sam's West Inc

Identifiers & Regulatory

Product NDC 68196-413
Product ID 68196-413_f8834e23-1240-4098-95f2-c8e31d6c2c64
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078336
Listing Expiration 2026-12-31
Marketing Start 2024-03-08

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 68196413
Hyphenated Format 68196-413

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 members mark allergy relief (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA078336 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 2 BOTTLE in 1 PACKAGE (68196-413-79) / 200 TABLET, FILM COATED in 1 BOTTLE (68196-413-82)
source: ndc

Packages (1)

68196-413-79 2 BOTTLE in 1 PACKAGE (68196-413-79) / 200 TABLET, FILM COATED in 1 BOTTLE (68196-413-82)

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Members Mark Allergy Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f8834e23-1240-4098-95f2-c8e31d6c2c64", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["379756fd-f92d-4773-94fd-2682fcbdfba2"], "manufacturer_name": ["Sam's West Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE in 1 PACKAGE (68196-413-79)  / 200 TABLET, FILM COATED in 1 BOTTLE (68196-413-82)", "package_ndc": "68196-413-79", "marketing_start_date": "20240308"}], "brand_name": "Members Mark Allergy Relief", "product_id": "68196-413_f8834e23-1240-4098-95f2-c8e31d6c2c64", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68196-413", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Sam's West Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Members Mark Allergy Relief", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078336", "marketing_category": "ANDA", "marketing_start_date": "20240308", "listing_expiration_date": "20261231"}