loratadine d

Generic: loratadine, pseudoephedrine sulfate

Labeler: sportpharm llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine d
Generic Name loratadine, pseudoephedrine sulfate
Labeler sportpharm llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

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

Manufacturer
Sportpharm LLC

Identifiers & Regulatory

Product NDC 85766-047
Product ID 85766-047_4a2c3181-73fa-906a-e063-6294a90a6479
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076050
Listing Expiration 2027-12-31
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 85766047
Hyphenated Format 85766-047

Supplemental Identifiers

RxCUI
1242399
UNII
7AJO3BO7QN Y9DL7QPE6B

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 (85766-047-10) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

85766-047-10 10 BLISTER PACK in 1 CARTON (85766-047-10) / 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": "4a2c3181-73fa-906a-e063-6294a90a6479", "openfda": {"unii": ["7AJO3BO7QN", "Y9DL7QPE6B"], "rxcui": ["1242399"], "spl_set_id": ["bb54f613-b2ab-48fd-83c9-2038ec7097f6"], "manufacturer_name": ["Sportpharm LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (85766-047-10)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "85766-047-10", "marketing_start_date": "20250802"}], "brand_name": "loratadine D", "product_id": "85766-047_4a2c3181-73fa-906a-e063-6294a90a6479", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "85766-047", "generic_name": "loratadine, Pseudoephedrine sulfate", "labeler_name": "Sportpharm LLC", "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": "20271231"}