loratadine

Generic: loratadine

Labeler: bi-mart
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler bi-mart
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Bi-Mart

Identifiers & Regulatory

Product NDC 37835-621
Product ID 37835-621_327a1a00-8532-2756-e063-6394a90a5e29
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 37835621
Hyphenated Format 37835-621

Supplemental Identifiers

RxCUI
311372
UPC
0071357911509
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 (37835-621-01)
  • 10 TABLET in 1 BOTTLE (37835-621-10)
  • 30 TABLET in 1 BOTTLE (37835-621-30)
source: ndc

Packages (3)

37835-621-01 100 TABLET in 1 BOTTLE (37835-621-01) 37835-621-10 10 TABLET in 1 BOTTLE (37835-621-10) 37835-621-30 30 TABLET in 1 BOTTLE (37835-621-30)

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": "327a1a00-8532-2756-e063-6394a90a5e29", "openfda": {"upc": ["0071357911509"], "unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["1dd299e7-dfdd-459b-bb2b-83e37dd2e63d"], "manufacturer_name": ["Bi-Mart"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (37835-621-01)", "package_ndc": "37835-621-01", "marketing_start_date": "20250301"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (37835-621-10)", "package_ndc": "37835-621-10", "marketing_start_date": "20250301"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (37835-621-30)", "package_ndc": "37835-621-30", "marketing_start_date": "20250301"}], "brand_name": "Loratadine", "product_id": "37835-621_327a1a00-8532-2756-e063-6394a90a5e29", "dosage_form": "TABLET", "product_ndc": "37835-621", "generic_name": "Loratadine", "labeler_name": "Bi-Mart", "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"}