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 58602-702
Product ID 58602-702_94169799-0508-439b-93c5-132b9e6ae767
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 58602702
Hyphenated Format 58602-702

Supplemental Identifiers

RxCUI
311372
UPC
0358602702175
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
  • 10 BLISTER PACK in 1 CARTON (58602-702-04) / 10 TABLET in 1 BLISTER PACK
  • 5 BLISTER PACK in 1 CARTON (58602-702-05) / 10 TABLET in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (58602-702-09) / 30 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-702-15) / 60 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-702-17) / 45 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-702-19) / 90 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-702-21) / 100 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-702-23) / 120 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-702-29) / 150 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-702-32) / 180 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-702-38) / 300 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-702-39) / 365 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-702-40) / 500 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-702-44) / 400 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-702-54) / 70 TABLET in 1 BOTTLE
  • 1 BLISTER PACK in 1 CARTON (58602-702-60) / 5 TABLET in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (58602-702-67) / 10 TABLET in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (58602-702-81) / 108 TABLET in 1 BOTTLE
  • 1 BLISTER PACK in 1 CARTON (58602-702-83) / 10 TABLET in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (58602-702-84) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (20)

58602-702-04 10 BLISTER PACK in 1 CARTON (58602-702-04) / 10 TABLET in 1 BLISTER PACK 58602-702-05 5 BLISTER PACK in 1 CARTON (58602-702-05) / 10 TABLET in 1 BLISTER PACK 58602-702-09 1 BOTTLE in 1 CARTON (58602-702-09) / 30 TABLET in 1 BOTTLE 58602-702-15 1 BOTTLE in 1 CARTON (58602-702-15) / 60 TABLET in 1 BOTTLE 58602-702-17 1 BOTTLE in 1 CARTON (58602-702-17) / 45 TABLET in 1 BOTTLE 58602-702-19 1 BOTTLE in 1 CARTON (58602-702-19) / 90 TABLET in 1 BOTTLE 58602-702-21 1 BOTTLE in 1 CARTON (58602-702-21) / 100 TABLET in 1 BOTTLE 58602-702-23 1 BOTTLE in 1 CARTON (58602-702-23) / 120 TABLET in 1 BOTTLE 58602-702-29 1 BOTTLE in 1 CARTON (58602-702-29) / 150 TABLET in 1 BOTTLE 58602-702-32 1 BOTTLE in 1 CARTON (58602-702-32) / 180 TABLET in 1 BOTTLE 58602-702-38 1 BOTTLE in 1 CARTON (58602-702-38) / 300 TABLET in 1 BOTTLE 58602-702-39 1 BOTTLE in 1 CARTON (58602-702-39) / 365 TABLET in 1 BOTTLE 58602-702-40 1 BOTTLE in 1 CARTON (58602-702-40) / 500 TABLET in 1 BOTTLE 58602-702-44 1 BOTTLE in 1 CARTON (58602-702-44) / 400 TABLET in 1 BOTTLE 58602-702-54 1 BOTTLE in 1 CARTON (58602-702-54) / 70 TABLET in 1 BOTTLE 58602-702-60 1 BLISTER PACK in 1 CARTON (58602-702-60) / 5 TABLET in 1 BLISTER PACK 58602-702-67 2 BLISTER PACK in 1 CARTON (58602-702-67) / 10 TABLET in 1 BLISTER PACK 58602-702-81 1 BOTTLE in 1 CARTON (58602-702-81) / 108 TABLET in 1 BOTTLE 58602-702-83 1 BLISTER PACK in 1 CARTON (58602-702-83) / 10 TABLET in 1 BLISTER PACK 58602-702-84 3 BLISTER PACK in 1 CARTON (58602-702-84) / 10 TABLET in 1 BLISTER PACK

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": "94169799-0508-439b-93c5-132b9e6ae767", "openfda": {"upc": ["0358602702175"], "unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["196da80c-3dbb-40c7-ac93-8a57d6acb1c3"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (58602-702-04)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "58602-702-04", "marketing_start_date": "20200210"}, {"sample": false, "description": "5 BLISTER PACK in 1 CARTON (58602-702-05)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "58602-702-05", "marketing_start_date": "20180416"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-702-09)  / 30 TABLET in 1 BOTTLE", "package_ndc": "58602-702-09", "marketing_start_date": "20190503"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-702-15)  / 60 TABLET in 1 BOTTLE", "package_ndc": "58602-702-15", "marketing_start_date": "20180416"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-702-17)  / 45 TABLET in 1 BOTTLE", "package_ndc": "58602-702-17", "marketing_start_date": "20180416"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-702-19)  / 90 TABLET in 1 BOTTLE", "package_ndc": "58602-702-19", "marketing_start_date": "20180416"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-702-21)  / 100 TABLET in 1 BOTTLE", "package_ndc": "58602-702-21", "marketing_start_date": "20191223"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-702-23)  / 120 TABLET in 1 BOTTLE", "package_ndc": "58602-702-23", "marketing_start_date": "20191004"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-702-29)  / 150 TABLET in 1 BOTTLE", "package_ndc": "58602-702-29", "marketing_start_date": "20200813"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-702-32)  / 180 TABLET in 1 BOTTLE", "package_ndc": "58602-702-32", "marketing_start_date": "20180416"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-702-38)  / 300 TABLET in 1 BOTTLE", "package_ndc": "58602-702-38", "marketing_start_date": "20190503"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-702-39)  / 365 TABLET in 1 BOTTLE", "package_ndc": "58602-702-39", "marketing_start_date": "20190503"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-702-40)  / 500 TABLET in 1 BOTTLE", "package_ndc": "58602-702-40", "marketing_start_date": "20191128"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-702-44)  / 400 TABLET in 1 BOTTLE", "package_ndc": "58602-702-44", "marketing_start_date": "20190726"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-702-54)  / 70 TABLET in 1 BOTTLE", "package_ndc": "58602-702-54", "marketing_start_date": "20191004"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (58602-702-60)  / 5 TABLET in 1 BLISTER PACK", "package_ndc": "58602-702-60", "marketing_start_date": "20180416"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (58602-702-67)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "58602-702-67", "marketing_start_date": "20180416"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-702-81)  / 108 TABLET in 1 BOTTLE", "package_ndc": "58602-702-81", "marketing_start_date": "20180416"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (58602-702-83)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "58602-702-83", "marketing_start_date": "20180416"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (58602-702-84)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "58602-702-84", "marketing_start_date": "20180416"}], "brand_name": "Loratadine", "product_id": "58602-702_94169799-0508-439b-93c5-132b9e6ae767", "dosage_form": "TABLET", "product_ndc": "58602-702", "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"}