loratadine odt

Generic: loratadine

Labeler: amerisource bergen
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine odt
Generic Name loratadine
Labeler amerisource bergen
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Amerisource Bergen

Identifiers & Regulatory

Product NDC 46122-539
Product ID 46122-539_64ce24cf-4a83-4d87-a5c8-0e9a7589fb13
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208477
Listing Expiration 2026-12-31
Marketing Start 2018-07-09

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46122539
Hyphenated Format 46122-539

Supplemental Identifiers

RxCUI
311373
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 odt (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA208477 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (46122-539-52) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (46122-539-65) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
source: ndc

Packages (2)

46122-539-52 1 BLISTER PACK in 1 CARTON (46122-539-52) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 46122-539-65 3 BLISTER PACK in 1 CARTON (46122-539-65) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Ingredients (1)

loratadine (10 mg/1)

Linked Drug Pages (1)

Loratadine ODT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "64ce24cf-4a83-4d87-a5c8-0e9a7589fb13", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311373"], "spl_set_id": ["d2524455-b6c4-442b-b139-666a555c5298"], "manufacturer_name": ["Amerisource Bergen"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (46122-539-52)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "46122-539-52", "marketing_start_date": "20180709"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (46122-539-65)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "46122-539-65", "marketing_start_date": "20220810"}], "brand_name": "Loratadine ODT", "product_id": "46122-539_64ce24cf-4a83-4d87-a5c8-0e9a7589fb13", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "product_ndc": "46122-539", "generic_name": "Loratadine", "labeler_name": "Amerisource Bergen", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine ODT", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA208477", "marketing_category": "ANDA", "marketing_start_date": "20180709", "listing_expiration_date": "20261231"}