loratadine d

Generic: loratadine, pseudoephedrine sulfate

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine d
Generic Name loratadine, pseudoephedrine sulfate
Labeler padagis israel pharmaceuticals ltd
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

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

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-122
Product ID 45802-122_64fa8aa8-ec51-4129-88d1-b1a8651061f6
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076050
Listing Expiration 2026-12-31
Marketing Start 2018-04-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802122
Hyphenated Format 45802-122

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 loratadine d (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
  • 10 BLISTER PACK in 1 CARTON (45802-122-46) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • 20 BLISTER PACK in 1 CARTON (45802-122-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • 30 BLISTER PACK in 1 CARTON (45802-122-65) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (3)

45802-122-46 10 BLISTER PACK in 1 CARTON (45802-122-46) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 45802-122-60 20 BLISTER PACK in 1 CARTON (45802-122-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 45802-122-65 30 BLISTER PACK in 1 CARTON (45802-122-65) / 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)

loratadine D ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "64fa8aa8-ec51-4129-88d1-b1a8651061f6", "openfda": {"unii": ["7AJO3BO7QN", "Y9DL7QPE6B"], "rxcui": ["1242399"], "spl_set_id": ["01e61c73-3b81-4683-b1a9-8784c0d565b1"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (45802-122-46)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "45802-122-46", "marketing_start_date": "20180410"}, {"sample": false, "description": "20 BLISTER PACK in 1 CARTON (45802-122-60)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "45802-122-60", "marketing_start_date": "20180410"}, {"sample": false, "description": "30 BLISTER PACK in 1 CARTON (45802-122-65)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "45802-122-65", "marketing_start_date": "20180410"}], "brand_name": "loratadine D", "product_id": "45802-122_64fa8aa8-ec51-4129-88d1-b1a8651061f6", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "45802-122", "generic_name": "loratadine, Pseudoephedrine sulfate", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "loratadine D", "active_ingredients": [{"name": "LORATADINE", "strength": "5 mg/1"}, {"name": "PSEUDOEPHEDRINE SULFATE", "strength": "120 mg/1"}], "application_number": "ANDA076050", "marketing_category": "ANDA", "marketing_start_date": "20180410", "listing_expiration_date": "20261231"}