loratadine and pseudoephedrine sulfate (62011-0071)

Drug Facts

Product Profile

Brand Name loratadine and pseudoephedrine sulfate

Generic Name loratadine and pseudoephedrine sulfate

Labeler strategic sourcing services llc

Dosage Form TABLET, FILM COATED, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

loratadine 10 mg/1, pseudoephedrine sulfate 240 mg/1

Manufacturer

Strategic Sourcing Services LLC

Identifiers & Regulatory

Product NDC 62011-0071

Product ID 62011-0071_277a549e-abcb-2621-e063-6394a90aa55c

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA076557

Listing Expiration 2026-12-31

Marketing Start 2017-06-06

Pharmacologic Class

Classes

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 620110071

Hyphenated Format 62011-0071

Supplemental Identifiers

RxCUI

1117562

UPC

0052569140390

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 loratadine and pseudoephedrine sulfate (source: ndc)

Generic Name loratadine and pseudoephedrine sulfate (source: ndc)

Application Number ANDA076557 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1
240 mg/1

source: ndc

Packaging

15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (62011-0071-2)

source: ndc

Packages (1)

62011-0071-2 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (62011-0071-2)

Ingredients (2)

loratadine (10 mg/1) pseudoephedrine sulfate (240 mg/1)

Linked Drug Pages (2)

Loratadine and Pseudoephedrine Sulfate ndc-match (0.9) Loratadine and Pseudoephedrine Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "277a549e-abcb-2621-e063-6394a90aa55c", "openfda": {"upc": ["0052569140390"], "unii": ["7AJO3BO7QN", "Y9DL7QPE6B"], "rxcui": ["1117562"], "spl_set_id": ["cdecad62-bf1e-43fb-b4be-8fc54b63e4ae"], "manufacturer_name": ["Strategic Sourcing Services LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (62011-0071-2)", "package_ndc": "62011-0071-2", "marketing_start_date": "20170606"}], "brand_name": "Loratadine and Pseudoephedrine Sulfate", "product_id": "62011-0071_277a549e-abcb-2621-e063-6394a90aa55c", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "62011-0071", "generic_name": "Loratadine and Pseudoephedrine Sulfate", "labeler_name": "Strategic Sourcing Services LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine and Pseudoephedrine Sulfate", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}, {"name": "PSEUDOEPHEDRINE SULFATE", "strength": "240 mg/1"}], "application_number": "ANDA076557", "marketing_category": "ANDA", "marketing_start_date": "20170606", "listing_expiration_date": "20261231"}