loratadine and pseudoephedrine sulfate (46122-167)

Drug Facts

Product Profile

Brand Name loratadine and pseudoephedrine sulfate

Generic Name loratadine and pseudoephedrine sulfate

Labeler amerisource bergen

Dosage Form TABLET, FILM COATED, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

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

Manufacturer

Amerisource Bergen

Identifiers & Regulatory

Product NDC 46122-167

Product ID 46122-167_747b20a8-c3a3-45dd-9212-f5074a010c6c

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA076557

Listing Expiration 2026-12-31

Marketing Start 2004-11-17

Pharmacologic Class

Classes

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46122167

Hyphenated Format 46122-167

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 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

10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (46122-167-52)

source: ndc

Packages (1)

46122-167-52 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (46122-167-52)

Ingredients (2)

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

Linked Drug Pages (1)

Loratadine and Pseudoephedrine Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "747b20a8-c3a3-45dd-9212-f5074a010c6c", "openfda": {"unii": ["7AJO3BO7QN", "Y9DL7QPE6B"], "rxcui": ["1117562"], "spl_set_id": ["3013f7b8-d87c-41ab-ba6f-c4d1b39cb1c1"], "manufacturer_name": ["Amerisource Bergen"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (46122-167-52)", "package_ndc": "46122-167-52", "marketing_start_date": "20041117"}], "brand_name": "Loratadine and Pseudoephedrine Sulfate", "product_id": "46122-167_747b20a8-c3a3-45dd-9212-f5074a010c6c", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "46122-167", "generic_name": "Loratadine and Pseudoephedrine Sulfate", "labeler_name": "Amerisource Bergen", "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": "20041117", "listing_expiration_date": "20261231"}