loratadine

Generic: loratadine

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

Drug Facts

Product Profile

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

loratadine 10 mg/1

Manufacturer
Rising Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 16571-822
Product ID 16571-822_8b088034-c702-4b88-b4e3-421aa9739ec8
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA214684
Listing Expiration 2026-12-31
Marketing Start 2022-03-10

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571822
Hyphenated Format 16571-822

Supplemental Identifiers

RxCUI
311372
UPC
0316571822010 0316571822034
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 ANDA214684 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (16571-822-01)
  • 30 TABLET in 1 BOTTLE (16571-822-03)
  • 300 TABLET in 1 BOTTLE (16571-822-30)
source: ndc

Packages (3)

16571-822-01 100 TABLET in 1 BOTTLE (16571-822-01) 16571-822-03 30 TABLET in 1 BOTTLE (16571-822-03) 16571-822-30 300 TABLET in 1 BOTTLE (16571-822-30)

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": "8b088034-c702-4b88-b4e3-421aa9739ec8", "openfda": {"upc": ["0316571822010", "0316571822034"], "unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["d28128a3-af54-440e-9bd4-0fccf393d18a"], "manufacturer_name": ["Rising Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (16571-822-01)", "package_ndc": "16571-822-01", "marketing_start_date": "20220310"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (16571-822-03)", "package_ndc": "16571-822-03", "marketing_start_date": "20220310"}, {"sample": false, "description": "300 TABLET in 1 BOTTLE (16571-822-30)", "package_ndc": "16571-822-30", "marketing_start_date": "20220310"}], "brand_name": "Loratadine", "product_id": "16571-822_8b088034-c702-4b88-b4e3-421aa9739ec8", "dosage_form": "TABLET", "product_ndc": "16571-822", "generic_name": "loratadine", "labeler_name": "Rising Pharmaceuticals, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA214684", "marketing_category": "ANDA", "marketing_start_date": "20220310", "listing_expiration_date": "20261231"}