loratadine

Generic: loratadine

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler aurohealth llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-831
Product ID 58602-831_de409efa-eff4-47fb-a6c6-a22be0587553
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208314
Listing Expiration 2026-12-31
Marketing Start 2018-04-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58602831
Hyphenated Format 58602-831

Supplemental Identifiers

RxCUI
311372
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 ANDA208314 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (58602-831-17) / 45 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-831-19) / 90 TABLET in 1 BOTTLE
source: ndc

Packages (2)

58602-831-17 1 BOTTLE in 1 CARTON (58602-831-17) / 45 TABLET in 1 BOTTLE 58602-831-19 1 BOTTLE in 1 CARTON (58602-831-19) / 90 TABLET 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": "de409efa-eff4-47fb-a6c6-a22be0587553", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["839e2e03-9ebb-4a44-b753-fb174bd36115"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-831-17)  / 45 TABLET in 1 BOTTLE", "package_ndc": "58602-831-17", "marketing_start_date": "20180416"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-831-19)  / 90 TABLET in 1 BOTTLE", "package_ndc": "58602-831-19", "marketing_start_date": "20180416"}], "brand_name": "Loratadine", "product_id": "58602-831_de409efa-eff4-47fb-a6c6-a22be0587553", "dosage_form": "TABLET", "product_ndc": "58602-831", "generic_name": "Loratadine", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA208314", "marketing_category": "ANDA", "marketing_start_date": "20180416", "listing_expiration_date": "20261231"}