NDC 80425-0352-01 - Loratadine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0352
Requested NDC
80425-0352-01
Package NDCs from labels
80425-0352-1, 80425-0352-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Loratadine - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0352-1Loratadine30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0352LORATADINE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 1 package rows20250102_01cb43cf-57a9-f189-e063-6294a90afd88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0352-1EA - Each80425-0352f9390c79-9ee4-4e64-97a1-db6be06a732812023-09-05

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 13 of 24 · 463 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LoratadineLORATADINE ORALAurohealth LLC0b86a9fe-db7e-470a-a8fa-d7d4373116ba2025-01-20WarningsExact identifier
unii: 7AJO3BO7QN
Loratadine antihistamineLORATADINENuCare Pharmaceuticals,Inc.54b37bcc-a8b0-0c17-e054-00144ff8d46c2025-01-09WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LORATADINELORATADINEAMZ789 LLCdb71197e-d633-644d-e053-2a95a90a261d2025-01-08WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LORATADINELORATADINECVS PHARMACY, INC4e74e322-7f6e-467c-96c0-9b531ddb429b2024-12-31WarningsExact identifier
unii: 7AJO3BO7QN
ClaritinLORATADINE TABLETLil' Drug Store Products, Inc.f0e77162-c601-1a0f-e053-2a95a90ab7142024-12-31WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINEAdvanced Rx Pharmacy of Tennessee, LLC01cb43cf-57a9-f189-e063-6294a90afd882024-12-31WarningsExact identifier
application number: ANDA214684
ndc (package): 80425-0352-1
ndc (product): 80425-0352
ndc11 (package): 80425035201
rxcui: 311372
spl id: 2a9c2eb6-a6de-f647-e063-6294a90a93fe
spl set id: 01cb43cf-57a9-f189-e063-6294a90afd88
unii: 7AJO3BO7QN
CHILDRENS LORATADINELORATADINESAFEWAYdad93ac1-ae0b-4918-8c62-92107e79a4b22024-12-29WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEWALGREEN COMPANY645c26ab-08ab-4a69-ae7d-7802d8ec59222024-12-29WarningsExact identifier
unii: 7AJO3BO7QN
Wal-itinLORATADINEWalgreens176fe4f5-f72d-4fc2-bd9a-20626c9ab6342024-12-27WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEPremier Valuedc22862e-fe91-4900-8c2b-1ca45aeedbf02024-12-27WarningsExact identifier
unii: 7AJO3BO7QN
CHILDRENS LORATADINELORATADINETARGET CORPORATIONc02ad905-2363-4092-a90e-3be789112cb12024-12-27WarningsExact identifier
unii: 7AJO3BO7QN
Childrens AllergyLORATADINETARGET CORPORATION9507c223-ea75-477e-b765-f5d0bcba5ff92024-12-27WarningsExact identifier
unii: 7AJO3BO7QN
AllervarxLORATADINEInnovus Pharmaceuticals, Inc.ec4d1e77-6995-4228-8e63-a9ab6232dace2024-12-27WarningsExact identifier
unii: 7AJO3BO7QN
AllervarxLORATADINEInnovus Pharmaceuticals, Inc.885e81ae-5ea3-4d14-8666-8c26987670142024-12-27WarningsExact identifier
unii: 7AJO3BO7QN
LORATADINELORATADINEBionpharma Inc.4fa705fb-859e-4046-b153-a8338c50a97d2024-12-23WarningsExact identifier
unii: 7AJO3BO7QN
Sunmark childrens loratadineLORATADINEStrategic Sourcing Services LLCed94cba7-c2c4-4cbe-9021-f554a51d51f22024-12-19WarningsExact identifier
unii: 7AJO3BO7QN
Childrens LoratadineLORATADINEStrategic Sourcing Services LLC280739e5-94e5-4d1e-ba65-2b4304cbac972024-12-19WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINESpirit Pharmaceuticals LLCaf0cdab2-27a4-5f30-e053-2a95a90a5e712024-12-13WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
foster and thrive allergy reliefLORATADINEStrategic Sourcing Services LLCaff1ab34-51b0-488c-931e-c95aad2265722024-12-11WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
good neighbor pharmacy loratadineLORATADINEAmerisource Bergen9dda0f0b-fbab-47ee-8db8-95bd126fc61c2024-12-11WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.