loratadine and pseudoephedrine (46122-383)

Drug Facts

Product Profile

Brand Name loratadine and pseudoephedrine

Generic Name loratadine and pseudoephedrine

Labeler amerisource bergen

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

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

Manufacturer

AMERISOURCE BERGEN

Identifiers & Regulatory

Product NDC 46122-383

Product ID 46122-383_39ace1fb-0f76-4ff6-8846-e6316ee972e5

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA076557

Listing Expiration 2026-12-31

Marketing Start 2017-08-02

Pharmacologic Class

Classes

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46122383

Hyphenated Format 46122-383

Supplemental Identifiers

RxCUI

1117562

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 (source: ndc)

Generic Name loratadine and pseudoephedrine (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, EXTENDED RELEASE in 1 BLISTER PACK (46122-383-22)

source: ndc

Packages (1)

46122-383-22 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (46122-383-22)

Ingredients (2)

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

Linked Drug Pages (1)

Loratadine and Pseudoephedrine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "39ace1fb-0f76-4ff6-8846-e6316ee972e5", "openfda": {"unii": ["7AJO3BO7QN", "Y9DL7QPE6B"], "rxcui": ["1117562"], "spl_set_id": ["96635cb0-8c78-4c3a-8294-2804ff26f90a"], "manufacturer_name": ["AMERISOURCE BERGEN"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (46122-383-22)", "package_ndc": "46122-383-22", "marketing_start_date": "20170802"}], "brand_name": "Loratadine and Pseudoephedrine", "product_id": "46122-383_39ace1fb-0f76-4ff6-8846-e6316ee972e5", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "46122-383", "generic_name": "loratadine and pseudoephedrine", "labeler_name": "AMERISOURCE BERGEN", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine and Pseudoephedrine", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}, {"name": "PSEUDOEPHEDRINE SULFATE", "strength": "240 mg/1"}], "application_number": "ANDA076557", "marketing_category": "ANDA", "marketing_start_date": "20170802", "listing_expiration_date": "20261231"}