allervarx

Generic: loratadine

Labeler: innovus pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name allervarx
Generic Name loratadine
Labeler innovus pharmaceuticals, inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Innovus Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 57483-950
Product ID 57483-950_d91b9ee4-dbd2-459c-a789-a59b7bf61d0e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA213294
Listing Expiration 2026-12-31
Marketing Start 2022-05-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57483950
Hyphenated Format 57483-950

Supplemental Identifiers

RxCUI
311373
UPC
0357483002329
UNII
7AJO3BO7QN

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 allervarx (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA213294 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (57483-950-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
source: ndc

Packages (1)

57483-950-10 3 BLISTER PACK in 1 CARTON (57483-950-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Ingredients (1)

loratadine (10 mg/1)

Linked Drug Pages (1)

Allervarx ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d91b9ee4-dbd2-459c-a789-a59b7bf61d0e", "openfda": {"upc": ["0357483002329"], "unii": ["7AJO3BO7QN"], "rxcui": ["311373"], "spl_set_id": ["885e81ae-5ea3-4d14-8666-8c2698767014"], "manufacturer_name": ["Innovus Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (57483-950-10)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "57483-950-10", "marketing_start_date": "20220530"}], "brand_name": "Allervarx", "product_id": "57483-950_d91b9ee4-dbd2-459c-a789-a59b7bf61d0e", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "product_ndc": "57483-950", "generic_name": "Loratadine", "labeler_name": "Innovus Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Allervarx", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA213294", "marketing_category": "ANDA", "marketing_start_date": "20220530", "listing_expiration_date": "20261231"}