allergy and congestion relief

Generic: loratadine, pseudoephedrine sulfate

Labeler: l. perrigo company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name allergy and congestion relief
Generic Name loratadine, pseudoephedrine sulfate
Labeler l. perrigo company
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

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

Manufacturer
L. Perrigo Company

Identifiers & Regulatory

Product NDC 0113-2007
Product ID 0113-2007_625c73b9-b448-4e9b-a1e6-359d5cb33eb0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076050
Listing Expiration 2026-12-31
Marketing Start 2018-04-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01132007
Hyphenated Format 0113-2007

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 allergy and congestion relief (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
  • 20 BLISTER PACK in 1 CARTON (0113-2007-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

0113-2007-60 20 BLISTER PACK in 1 CARTON (0113-2007-60) / 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)

Allergy and Congestion Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "625c73b9-b448-4e9b-a1e6-359d5cb33eb0", "openfda": {"unii": ["7AJO3BO7QN", "Y9DL7QPE6B"], "rxcui": ["1242399"], "spl_set_id": ["b5589371-48bc-44a5-bcab-018a92e22796"], "manufacturer_name": ["L. Perrigo Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 CARTON (0113-2007-60)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0113-2007-60", "marketing_start_date": "20180412"}], "brand_name": "Allergy and Congestion Relief", "product_id": "0113-2007_625c73b9-b448-4e9b-a1e6-359d5cb33eb0", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "0113-2007", "generic_name": "loratadine, Pseudoephedrine sulfate", "labeler_name": "L. Perrigo Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Allergy and Congestion Relief", "active_ingredients": [{"name": "LORATADINE", "strength": "5 mg/1"}, {"name": "PSEUDOEPHEDRINE SULFATE", "strength": "120 mg/1"}], "application_number": "ANDA076050", "marketing_category": "ANDA", "marketing_start_date": "20180412", "listing_expiration_date": "20261231"}