FDA.reportPublic FDA data

NDC 63548-0753-01 - 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
63548-0753
Requested NDC
63548-0753-01
Package NDCs from labels
63548-0753-3, 63548-0753-1, 63548-0753-0, 63548-0753-01
Manufacturer
PLD Acquisitions LLC DBA Avéma Pharma Solutions
Effective date
2023-05-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Loratadine - PLD Acquisitions LLC DBA Avéma Pharma SolutionsPLD Acquisitions LLC DBA Avéma Pharma Solutions2023-05-04HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63548-0753-02023-02-09Drug Facts
63548-0753-12023-02-09Drug Facts
63548-0753-32023-02-09Drug Facts
63548-0753-02023-01-30Drug Facts
63548-0753-12023-01-30Drug Facts
63548-0753-32023-01-30Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63548-0753-0Loratadine300 in 1 BOTTLE, PLASTICTABLET3006
63548-0753-1Loratadine100 in 1 BOTTLE, PLASTICTABLET1006
63548-0753-3Loratadine30 in 1 BOTTLE, PLASTICTABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63548-0753LORATADINE TABLET [PLD ACQUISITIONS LLC DBA AVÉMA PHARMA SOLUTIONS]6Current NDC, Legacy NDC, 3 package rows20230505_2edb53f8-7661-4e54-bb50-e03078bae3bf.zip

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 5 of 20 · 398 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LORATADINELORATADINEAdvagen Pharma Limiteda5699a95-c0a7-43ea-9bab-bbfaba3c8aa52026-01-05Exact identifier
unii: 7AJO3BO7QN
LORATADINELORATADINEKROGER COMPANY0599cc64-419d-452f-ac50-ac03110067292025-12-29WarningsExact identifier
unii: 7AJO3BO7QN
ClaritinLORATADINESelect Consumer Group3c9ad1f8-e8ef-bcd0-e063-6394a90ac20e2025-12-28WarningsExact identifier
application number: ANDA075209
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINEGRANULES USA, INC.c3c9bc45-7ed5-abf4-e053-2995a90a40ff2025-12-22WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine antihistamineLORATADINENCS HealthCare of KY, LLC dba Vangard Labsf3d05276-21bd-419d-8dba-07ce278d33752025-12-22WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINESafeway, Incf2a2a754-0170-e37c-e053-2a95a90a4dca2025-12-19WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine 10mgLORATADINE 10MGMeijer181b7dd1-ddc4-e799-e063-6294a90a9faa2025-12-19WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINEWalgreensfd796139-ea9f-f4db-e053-6394a90acdf32025-12-19WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Allergy ReliefLORATADINEValu Merchandisers Company05927511-6b7a-4e29-96b4-3043493acf112025-12-11WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINEMajor Pharmaceuticalsdee25423-377b-4b94-a4a8-0dfb8f51aaab2025-12-08WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine antihistamineLORATADINEA-S Medication Solutions1203981a-becd-4854-810d-b6d8842b5bd22025-12-06WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
ClaritinLORATADINEBayer HealthCare LLC.660ac9df-f1b1-4c89-94dd-9fae0a013f3c2025-12-05WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Claritin ReditabsLORATADINEBayer Healthcare LLC.b681ea25-d00b-4c8a-8054-cc6f983ce3372025-12-05WarningsExact identifier
unii: 7AJO3BO7QN
ClaritinLORATADINEBayer HealthCare LLC.37732ca2-b454-4215-91a2-c62e0f7a56af2025-12-05WarningsExact identifier
unii: 7AJO3BO7QN
Claritin-D 24 HourLORATADINE AND PSEUDOEPHEDRINE SULFATEBayer HealthCare LLC.f046a807-ab8c-0620-e053-2a95a90a9d3c2025-12-05WarningsExact identifier
unii: 7AJO3BO7QN
ClaritinLORATADINEBayer HealthCare LLC.20938e05-bc3e-51aa-e054-00144ff88e882025-12-05Exact identifier
unii: 7AJO3BO7QN
Claritin Chewable Cool Mint FlavorLORATADINEBayer HealthCare LLC.98b99bb9-d499-9ab4-e053-2a95a90a6ae62025-12-05WarningsExact identifier
unii: 7AJO3BO7QN
Claritin-D 12 HourLORATADINE AND PSEUDOEPHEDRINE SULFATEBayer HealthCare LLC.a7125705-01ff-4418-8c53-9209c2bbb4842025-12-05WarningsExact identifier
unii: 7AJO3BO7QN
Claritin ReditabsLORATADINEBayer HealthCare LLC7dc04b48-f053-4e4b-a493-9e8286d2a7912025-12-05WarningsExact identifier
unii: 7AJO3BO7QN
ClaritinLORATADINEBayer HealthCare LLCac32d6f9-f553-4d5c-ad36-575af5ea56de2025-12-04WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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