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 CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-818
Product ID 58602-818_cfa8d72c-3d1a-464c-b63a-b7b7525c1a3c
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211900
Listing Expiration 2026-12-31
Marketing Start 2023-03-24

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58602818
Hyphenated Format 58602-818

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 ANDA211900 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 5 BLISTER PACK in 1 CARTON (58602-818-05) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (58602-818-08) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (58602-818-67) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (58602-818-83) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (58602-818-84) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (5)

58602-818-05 5 BLISTER PACK in 1 CARTON (58602-818-05) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 58602-818-08 4 BLISTER PACK in 1 CARTON (58602-818-08) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 58602-818-67 2 BLISTER PACK in 1 CARTON (58602-818-67) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 58602-818-83 1 BLISTER PACK in 1 CARTON (58602-818-83) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 58602-818-84 3 BLISTER PACK in 1 CARTON (58602-818-84) / 10 CAPSULE, LIQUID FILLED 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": "cfa8d72c-3d1a-464c-b63a-b7b7525c1a3c", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["828269"], "spl_set_id": ["a057241d-a655-4847-9d2d-d45293f45d87"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 CARTON (58602-818-05)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "58602-818-05", "marketing_start_date": "20230324"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (58602-818-08)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "58602-818-08", "marketing_start_date": "20230324"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (58602-818-67)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "58602-818-67", "marketing_start_date": "20230324"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (58602-818-83)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "58602-818-83", "marketing_start_date": "20230324"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (58602-818-84)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "58602-818-84", "marketing_start_date": "20230324"}], "brand_name": "Loratadine", "product_id": "58602-818_cfa8d72c-3d1a-464c-b63a-b7b7525c1a3c", "dosage_form": "CAPSULE, LIQUID FILLED", "product_ndc": "58602-818", "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": "ANDA211900", "marketing_category": "ANDA", "marketing_start_date": "20230324", "listing_expiration_date": "20261231"}