loratadine

Generic: loratadine

Labeler: granules usa, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler granules usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
GRANULES USA, INC.

Identifiers & Regulatory

Product NDC 69848-019
Product ID 69848-019_469099a1-3de4-d107-e063-6294a90adf16
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210722
Listing Expiration 2026-12-31
Marketing Start 2021-07-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69848019
Hyphenated Format 69848-019

Supplemental Identifiers

RxCUI
311372
UPC
0813874020032
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 ANDA210722 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69848-019-10)
source: ndc

Packages (1)

69848-019-10 100 TABLET in 1 BOTTLE (69848-019-10)

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": "469099a1-3de4-d107-e063-6294a90adf16", "openfda": {"upc": ["0813874020032"], "unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["c3c9bc45-7ed5-abf4-e053-2995a90a40ff"], "manufacturer_name": ["GRANULES USA, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69848-019-10)", "package_ndc": "69848-019-10", "marketing_start_date": "20210726"}], "brand_name": "Loratadine", "product_id": "69848-019_469099a1-3de4-d107-e063-6294a90adf16", "dosage_form": "TABLET", "product_ndc": "69848-019", "generic_name": "Loratadine", "labeler_name": "GRANULES USA, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA210722", "marketing_category": "ANDA", "marketing_start_date": "20210726", "listing_expiration_date": "20261231"}