loratadine

Generic: loratadine

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

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler bionpharma inc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-211
Product ID 69452-211_932678d1-e6bf-4154-ac00-b6b9c9fbd16e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA202538
Listing Expiration 2026-12-31
Marketing Start 2019-03-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452211
Hyphenated Format 69452-211

Supplemental Identifiers

RxCUI
828269
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 ANDA202538 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (69452-211-03) / 5 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • 1 BLISTER PACK in 1 CARTON (69452-211-07) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (69452-211-16) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (69452-211-26) / 200 CAPSULE, LIQUID FILLED in 1 BOTTLE
source: ndc

Packages (4)

69452-211-03 1 BOTTLE in 1 CARTON (69452-211-03) / 5 CAPSULE, LIQUID FILLED in 1 BOTTLE 69452-211-07 1 BLISTER PACK in 1 CARTON (69452-211-07) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 69452-211-16 1 BOTTLE in 1 CARTON (69452-211-16) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE 69452-211-26 1 BOTTLE in 1 CARTON (69452-211-26) / 200 CAPSULE, LIQUID FILLED in 1 BOTTLE

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": "932678d1-e6bf-4154-ac00-b6b9c9fbd16e", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["828269"], "spl_set_id": ["59bebce3-2b82-4521-a796-2d4c83bcf669"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (69452-211-03)  / 5 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "69452-211-03", "marketing_start_date": "20190301"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (69452-211-07)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "69452-211-07", "marketing_start_date": "20190301"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69452-211-16)  / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "69452-211-16", "marketing_start_date": "20190301"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69452-211-26)  / 200 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "69452-211-26", "marketing_start_date": "20190301"}], "brand_name": "LORATADINE", "product_id": "69452-211_932678d1-e6bf-4154-ac00-b6b9c9fbd16e", "dosage_form": "CAPSULE, LIQUID FILLED", "product_ndc": "69452-211", "generic_name": "LORATADINE", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "LORATADINE", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA202538", "marketing_category": "ANDA", "marketing_start_date": "20190301", "listing_expiration_date": "20261231"}