loratadine

Generic: loratadine

Labeler: lannett company, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler lannett company, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

loratadine 5 mg/5mL

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 54838-554
Product ID 54838-554_fd40a94c-2173-4b80-a049-ab3c4faf24f4
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077421
Listing Expiration 2026-12-31
Marketing Start 2010-11-24

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54838554
Hyphenated Format 54838-554

Supplemental Identifiers

RxCUI
692783
UPC
0354838552409
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 ANDA077421 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 120 mL in 1 CARTON (54838-554-40)
source: ndc

Packages (1)

54838-554-40 120 mL in 1 CARTON (54838-554-40)

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": "fd40a94c-2173-4b80-a049-ab3c4faf24f4", "openfda": {"upc": ["0354838552409"], "unii": ["7AJO3BO7QN"], "rxcui": ["692783"], "spl_set_id": ["069c4e75-1f9f-4ab5-9570-3d93d12c2a23"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 CARTON (54838-554-40)", "package_ndc": "54838-554-40", "marketing_start_date": "20101124"}], "brand_name": "Loratadine", "product_id": "54838-554_fd40a94c-2173-4b80-a049-ab3c4faf24f4", "dosage_form": "SOLUTION", "product_ndc": "54838-554", "generic_name": "Loratadine", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "5 mg/5mL"}], "application_number": "ANDA077421", "marketing_category": "ANDA", "marketing_start_date": "20101124", "listing_expiration_date": "20261231"}