12 hour allergy d (41250-728)

Drug Facts

Product Profile

Brand Name 12 hour allergy d

Generic Name cetirizine hydrochloride, pseudoephedrine hydrochloride

Labeler meijer distribution inc

Dosage Form TABLET, FILM COATED, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

cetirizine hydrochloride 5 mg/1, pseudoephedrine hydrochloride 120 mg/1

Manufacturer

Meijer Distribution Inc

Identifiers & Regulatory

Product NDC 41250-728

Product ID 41250-728_dd51ee4f-bf5a-4237-9f86-6901325736a4

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA210719

Listing Expiration 2026-12-31

Marketing Start 2020-04-07

Pharmacologic Class

Classes

adrenergic alpha-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 41250728

Hyphenated Format 41250-728

Supplemental Identifiers

RxCUI

1014571

UNII

64O047KTOA 6V9V2RYJ8N

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 12 hour allergy d (source: ndc)

Generic Name cetirizine hydrochloride, pseudoephedrine hydrochloride (source: ndc)

Application Number ANDA210719 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
120 mg/1

source: ndc

Packaging

12 BLISTER PACK in 1 CARTON (41250-728-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
24 BLISTER PACK in 1 CARTON (41250-728-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (2)

41250-728-53 12 BLISTER PACK in 1 CARTON (41250-728-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 41250-728-62 24 BLISTER PACK in 1 CARTON (41250-728-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

cetirizine hydrochloride (5 mg/1) pseudoephedrine hydrochloride (120 mg/1)

Linked Drug Pages (1)

12 hour allergy d ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "dd51ee4f-bf5a-4237-9f86-6901325736a4", "openfda": {"unii": ["64O047KTOA", "6V9V2RYJ8N"], "rxcui": ["1014571"], "spl_set_id": ["b7019ea1-ca3d-4ddb-8cf4-e4ca7cb95e77"], "manufacturer_name": ["Meijer Distribution Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (41250-728-53)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "41250-728-53", "marketing_start_date": "20200407"}, {"sample": false, "description": "24 BLISTER PACK in 1 CARTON (41250-728-62)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "41250-728-62", "marketing_start_date": "20200407"}], "brand_name": "12 hour allergy d", "product_id": "41250-728_dd51ee4f-bf5a-4237-9f86-6901325736a4", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "41250-728", "generic_name": "cetirizine hydrochloride, pseudoephedrine hydrochloride", "labeler_name": "Meijer Distribution Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "12 hour allergy d", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA210719", "marketing_category": "ANDA", "marketing_start_date": "20200407", "listing_expiration_date": "20261231"}