loratadine and pseudoephedrine sulfate

Generic: loratadine and pseudoephedrine sulfate

Labeler: safeway inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine and pseudoephedrine sulfate
Generic Name loratadine and pseudoephedrine sulfate
Labeler safeway inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

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

Manufacturer
Safeway Inc.

Identifiers & Regulatory

Product NDC 21130-724
Product ID 21130-724_92f68316-fe4c-4e9f-8f18-cbb66ac6deae
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 21130724
Hyphenated Format 21130-724

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
  • 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (21130-724-15)
  • 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (21130-724-69)
source: ndc

Packages (2)

21130-724-15 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (21130-724-15) 21130-724-69 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (21130-724-69)

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": "92f68316-fe4c-4e9f-8f18-cbb66ac6deae", "openfda": {"unii": ["7AJO3BO7QN", "Y9DL7QPE6B"], "rxcui": ["1117562"], "spl_set_id": ["c1e1e0ca-30df-4ace-a7b6-c66a3c5ab676"], "manufacturer_name": ["Safeway Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (21130-724-15)", "package_ndc": "21130-724-15", "marketing_start_date": "20041117"}, {"sample": false, "description": "10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (21130-724-69)", "package_ndc": "21130-724-69", "marketing_start_date": "20041117"}], "brand_name": "Loratadine and Pseudoephedrine Sulfate", "product_id": "21130-724_92f68316-fe4c-4e9f-8f18-cbb66ac6deae", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "21130-724", "generic_name": "Loratadine and Pseudoephedrine Sulfate", "labeler_name": "Safeway Inc.", "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"}