loratadine

Generic: loratadine

Labeler: cardinal health, 110 dba leader
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler cardinal health, 110 dba leader
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

loratadine 5 mg/5mL

Manufacturer
Cardinal Health, 110 dba LEADER

Identifiers & Regulatory

Product NDC 70000-0125
Product ID 70000-0125_88e1fe57-4ad1-4646-b639-e935285aec4b
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076805
Listing Expiration 2026-12-31
Marketing Start 2004-08-20

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000125
Hyphenated Format 70000-0125

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 loratadine (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA076805 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70000-0125-1) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

70000-0125-1 1 BOTTLE in 1 CARTON (70000-0125-1) / 118 mL in 1 BOTTLE

Ingredients (1)

loratadine (5 mg/5mL)

Linked Drug Pages (1)

Loratadine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "88e1fe57-4ad1-4646-b639-e935285aec4b", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["692783"], "spl_set_id": ["db9d2182-6bf1-424a-a144-f2694c47989f"], "manufacturer_name": ["Cardinal Health, 110 dba LEADER"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0125-1)  / 118 mL in 1 BOTTLE", "package_ndc": "70000-0125-1", "marketing_start_date": "20161024"}], "brand_name": "Loratadine", "product_id": "70000-0125_88e1fe57-4ad1-4646-b639-e935285aec4b", "dosage_form": "SOLUTION", "product_ndc": "70000-0125", "generic_name": "Loratadine", "labeler_name": "Cardinal Health, 110 dba LEADER", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "5 mg/5mL"}], "application_number": "ANDA076805", "marketing_category": "ANDA", "marketing_start_date": "20040820", "listing_expiration_date": "20261231"}