childrens loratadine oral

Generic: loratadine

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

Drug Facts

Product Profile

Brand Name childrens loratadine oral
Generic Name loratadine
Labeler major pharmaceuticals
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

loratadine 5 mg/5mL

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6767
Product ID 0904-6767_efdb406d-9562-4ed6-b461-683c82e26a73
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075728
Listing Expiration 2026-12-31
Marketing Start 2019-02-12

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046767
Hyphenated Format 0904-6767

Supplemental Identifiers

RxCUI
692783
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 childrens loratadine oral (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA075728 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0904-6767-20) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

0904-6767-20 1 BOTTLE in 1 CARTON (0904-6767-20) / 120 mL in 1 BOTTLE

Ingredients (1)

loratadine (5 mg/5mL)

Linked Drug Pages (1)

Childrens Loratadine Oral ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "efdb406d-9562-4ed6-b461-683c82e26a73", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["692783"], "spl_set_id": ["3f0f0131-b516-4ff3-8049-3d3766324b66"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0904-6767-20)  / 120 mL in 1 BOTTLE", "package_ndc": "0904-6767-20", "marketing_start_date": "20190212"}], "brand_name": "Childrens Loratadine Oral", "product_id": "0904-6767_efdb406d-9562-4ed6-b461-683c82e26a73", "dosage_form": "SOLUTION", "product_ndc": "0904-6767", "generic_name": "Loratadine", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Loratadine Oral", "active_ingredients": [{"name": "LORATADINE", "strength": "5 mg/5mL"}], "application_number": "ANDA075728", "marketing_category": "ANDA", "marketing_start_date": "20190212", "listing_expiration_date": "20261231"}