loratadine

Generic: loratadine

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

Drug Facts

Product Profile

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

loratadine 10 mg/1

Manufacturer
Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-162
Product ID 70010-162_346155e4-f155-2f14-e063-6294a90ac61f
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 70010162
Hyphenated Format 70010-162

Supplemental Identifiers

RxCUI
311372
UPC
0370010162037
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 (70010-162-01)
  • 30 TABLET in 1 BOTTLE (70010-162-03)
  • 300 TABLET in 1 BOTTLE (70010-162-34)
source: ndc

Packages (3)

70010-162-01 100 TABLET in 1 BOTTLE (70010-162-01) 70010-162-03 30 TABLET in 1 BOTTLE (70010-162-03) 70010-162-34 300 TABLET in 1 BOTTLE (70010-162-34)

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": "346155e4-f155-2f14-e063-6294a90ac61f", "openfda": {"upc": ["0370010162037"], "unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["d15add22-bc2d-9730-e053-2a95a90acd3f"], "manufacturer_name": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70010-162-01)", "package_ndc": "70010-162-01", "marketing_start_date": "20211117"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (70010-162-03)", "package_ndc": "70010-162-03", "marketing_start_date": "20220501"}, {"sample": false, "description": "300 TABLET in 1 BOTTLE (70010-162-34)", "package_ndc": "70010-162-34", "marketing_start_date": "20220501"}], "brand_name": "Loratadine", "product_id": "70010-162_346155e4-f155-2f14-e063-6294a90ac61f", "dosage_form": "TABLET", "product_ndc": "70010-162", "generic_name": "Loratadine", "labeler_name": "Granules 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"}