loratadine and pseudoephedrine

Generic: loratadine and pseudoephedrine

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

Drug Facts

Product Profile

Brand Name loratadine and pseudoephedrine
Generic Name loratadine and pseudoephedrine
Labeler sportpharm llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

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

Manufacturer
Sportpharm LLC

Identifiers & Regulatory

Product NDC 85766-048
Product ID 85766-048_4a2c2629-df77-dec0-e063-6394a90a45a4
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076557
Listing Expiration 2027-12-31
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 85766048
Hyphenated Format 85766-048

Supplemental Identifiers

RxCUI
1117562
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 and pseudoephedrine (source: ndc)
Generic Name loratadine and pseudoephedrine (source: ndc)
Application Number ANDA076557 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
  • 240 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (85766-048-10) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

85766-048-10 1 BLISTER PACK in 1 CARTON (85766-048-10) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

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

Linked Drug Pages (1)

Loratadine and Pseudoephedrine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4a2c2629-df77-dec0-e063-6394a90a45a4", "openfda": {"unii": ["7AJO3BO7QN", "Y9DL7QPE6B"], "rxcui": ["1117562"], "spl_set_id": ["2b432b67-f9f3-45e2-8306-2d4080152f99"], "manufacturer_name": ["Sportpharm LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (85766-048-10)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "85766-048-10", "marketing_start_date": "20250802"}], "brand_name": "Loratadine and Pseudoephedrine", "product_id": "85766-048_4a2c2629-df77-dec0-e063-6394a90a45a4", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "85766-048", "generic_name": "loratadine and pseudoephedrine", "labeler_name": "Sportpharm LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine and Pseudoephedrine", "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": "20271231"}