loratadine

Generic: loratadine

Labeler: mylan institutional inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler mylan institutional inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Mylan Institutional Inc.

Identifiers & Regulatory

Product NDC 51079-246
Product ID 51079-246_3a865b90-4189-3e83-e063-6394a90aba53
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076154
Listing Expiration 2026-12-31
Marketing Start 2013-04-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51079246
Hyphenated Format 51079-246

Supplemental Identifiers

RxCUI
311372
UNII
7AJO3BO7QN

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 ANDA076154 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-246-20) / 1 TABLET in 1 BLISTER PACK (51079-246-01)
source: ndc

Packages (1)

51079-246-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-246-20) / 1 TABLET in 1 BLISTER PACK (51079-246-01)

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": "3a865b90-4189-3e83-e063-6394a90aba53", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["1fc9ddd1-393d-4fe2-a9e0-d192df7331db"], "manufacturer_name": ["Mylan Institutional Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-246-20)  / 1 TABLET in 1 BLISTER PACK (51079-246-01)", "package_ndc": "51079-246-20", "marketing_start_date": "20130430"}], "brand_name": "Loratadine", "product_id": "51079-246_3a865b90-4189-3e83-e063-6394a90aba53", "dosage_form": "TABLET", "product_ndc": "51079-246", "generic_name": "loratadine", "labeler_name": "Mylan Institutional Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA076154", "marketing_category": "ANDA", "marketing_start_date": "20130430", "listing_expiration_date": "20261231"}