loratadine

Generic: loratadine

Labeler: aurobindo pharma limited
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 84386-119
Product ID 84386-119_4f4ffb72-f4e8-4617-8bc5-61e6de488a2d
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208314
Listing Expiration 2026-12-31
Marketing Start 2025-11-12

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84386119
Hyphenated Format 84386-119

Supplemental Identifiers

RxCUI
311372
UPC
0384386119786
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 (84386-119-78) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

84386-119-78 10 BLISTER PACK in 1 CARTON (84386-119-78) / 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": "4f4ffb72-f4e8-4617-8bc5-61e6de488a2d", "openfda": {"upc": ["0384386119786"], "unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["4f4ffb72-f4e8-4617-8bc5-61e6de488a2d"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (84386-119-78)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "84386-119-78", "marketing_start_date": "20251112"}], "brand_name": "Loratadine", "product_id": "84386-119_4f4ffb72-f4e8-4617-8bc5-61e6de488a2d", "dosage_form": "TABLET", "product_ndc": "84386-119", "generic_name": "Loratadine", "labeler_name": "Aurobindo Pharma Limited", "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": "20251112", "listing_expiration_date": "20261231"}