loratadine

Generic: loratadine

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler nucare pharmaceuticals,inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3596
Product ID 68071-3596_200c6126-b08c-7aa4-e063-6394a90ab9db
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210722
Listing Expiration 2026-12-31
Marketing Start 2020-01-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713596
Hyphenated Format 68071-3596

Supplemental Identifiers

RxCUI
311372
UPC
0368071359695
UNII
7AJO3BO7QN

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
  • 60 TABLET in 1 BOTTLE (68071-3596-6)
  • 90 TABLET in 1 BOTTLE (68071-3596-9)
source: ndc

Packages (2)

Ingredients (1)

loratadine (10 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "200c6126-b08c-7aa4-e063-6394a90ab9db", "openfda": {"upc": ["0368071359695"], "unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["16f00a3a-0777-f70c-e063-6294a90a71c9"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (68071-3596-6)", "package_ndc": "68071-3596-6", "marketing_start_date": "20240425"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68071-3596-9)", "package_ndc": "68071-3596-9", "marketing_start_date": "20240425"}], "brand_name": "Loratadine", "product_id": "68071-3596_200c6126-b08c-7aa4-e063-6394a90ab9db", "dosage_form": "TABLET", "product_ndc": "68071-3596", "generic_name": "Loratadine", "labeler_name": "NuCare Pharmaceuticals,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": "20200101", "listing_expiration_date": "20261231"}