leader allergy relief d12 (70000-0504)

Drug Facts

Product Profile

Brand Name leader allergy relief d12

Generic Name loratadine, pseudoephedrine sulfate

Labeler cardinal health 110, llc. dba leader

Dosage Form TABLET, FILM COATED, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

loratadine 5 mg/1, pseudoephedrine sulfate 120 mg/1

Manufacturer

Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0504

Product ID 70000-0504_ae900734-0351-4a74-98a0-4af543e1882d

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA076050

Listing Expiration 2026-12-31

Marketing Start 2020-01-09

Pharmacologic Class

Classes

adrenergic alpha-agonists [moa] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000504

Hyphenated Format 70000-0504

Supplemental Identifiers

RxCUI

1242399

UNII

7AJO3BO7QN Y9DL7QPE6B

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 leader allergy relief d12 (source: ndc)

Generic Name loratadine, pseudoephedrine sulfate (source: ndc)

Application Number ANDA076050 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
120 mg/1

source: ndc

Packaging

10 BLISTER PACK in 1 CARTON (70000-0504-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
20 BLISTER PACK in 1 CARTON (70000-0504-2) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
30 BLISTER PACK in 1 CARTON (70000-0504-3) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (3)

70000-0504-1 10 BLISTER PACK in 1 CARTON (70000-0504-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 70000-0504-2 20 BLISTER PACK in 1 CARTON (70000-0504-2) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 70000-0504-3 30 BLISTER PACK in 1 CARTON (70000-0504-3) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

loratadine (5 mg/1) pseudoephedrine sulfate (120 mg/1)

Linked Drug Pages (1)

Leader Allergy Relief D12 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "ae900734-0351-4a74-98a0-4af543e1882d", "openfda": {"unii": ["7AJO3BO7QN", "Y9DL7QPE6B"], "rxcui": ["1242399"], "spl_set_id": ["98bd6186-2bd2-4f46-99df-f509bb00e03a"], "manufacturer_name": ["Cardinal Health 110, LLC. dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70000-0504-1)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "70000-0504-1", "marketing_start_date": "20200109"}, {"sample": false, "description": "20 BLISTER PACK in 1 CARTON (70000-0504-2)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "70000-0504-2", "marketing_start_date": "20200109"}, {"sample": false, "description": "30 BLISTER PACK in 1 CARTON (70000-0504-3)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "70000-0504-3", "marketing_start_date": "20200109"}], "brand_name": "Leader Allergy Relief D12", "product_id": "70000-0504_ae900734-0351-4a74-98a0-4af543e1882d", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "70000-0504", "generic_name": "loratadine, Pseudoephedrine sulfate", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Leader Allergy Relief D12", "active_ingredients": [{"name": "LORATADINE", "strength": "5 mg/1"}, {"name": "PSEUDOEPHEDRINE SULFATE", "strength": "120 mg/1"}], "application_number": "ANDA076050", "marketing_category": "ANDA", "marketing_start_date": "20200109", "listing_expiration_date": "20261231"}