loratadine

Generic: loratadine

Labeler: major pharmaceuticals
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7426
Product ID 0904-7426_8d4a63eb-4112-4312-93c2-05688ea201b3
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208314
Listing Expiration 2026-12-31
Marketing Start 2024-02-23

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047426
Hyphenated Format 0904-7426

Supplemental Identifiers

RxCUI
311372
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 loratadine (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA208314 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0904-7426-46) / 30 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0904-7426-59) / 100 TABLET in 1 BOTTLE
source: ndc

Packages (2)

0904-7426-46 1 BOTTLE in 1 CARTON (0904-7426-46) / 30 TABLET in 1 BOTTLE 0904-7426-59 1 BOTTLE in 1 CARTON (0904-7426-59) / 100 TABLET in 1 BOTTLE

Ingredients (1)

loratadine (10 mg/1)

Linked Drug Pages (1)

Loratadine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8d4a63eb-4112-4312-93c2-05688ea201b3", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["98e41ae1-677a-4583-9a0a-edba29ebbc30"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0904-7426-46)  / 30 TABLET in 1 BOTTLE", "package_ndc": "0904-7426-46", "marketing_start_date": "20240223"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0904-7426-59)  / 100 TABLET in 1 BOTTLE", "package_ndc": "0904-7426-59", "marketing_start_date": "20240223"}], "brand_name": "Loratadine", "product_id": "0904-7426_8d4a63eb-4112-4312-93c2-05688ea201b3", "dosage_form": "TABLET", "product_ndc": "0904-7426", "generic_name": "Loratadine", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA208314", "marketing_category": "ANDA", "marketing_start_date": "20240223", "listing_expiration_date": "20261231"}