NDC 48433-064-01 - 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: 48433-064
Requested NDC: 48433-064-01
Package NDCs from labels: 48433-064-01, 48433-064-20
Manufacturer: Safecor Health, LLC
Effective date: 2026-03-31
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Loratadine - Safecor Health, LLC	Safecor Health, LLC	2026-03-31	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
48433-064-01	Loratadine	1 in 1 BLISTER PACK	TABLET	1		2
48433-064-20	Loratadine	100 in 1 CARTON	TABLET	100		2

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 21 of 21 · 403 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Allergy	LORATADINE	CVS Pharmacy	dc5f58ef-baf0-4de4-9f6d-aedee419b59b	2017-10-02	Warnings	Exact identifier unii: 7AJO3BO7QN
Allergy	LORATADINE	Selder, S.A. de C.V.	afdb0117-dd2d-4ab1-a2f4-2a88b6bf5251	2016-12-22	Warnings	Exact identifier rxcui: 311372 unii: 7AJO3BO7QN
Loratadine	LORATADINE	Mylan Pharmaceuticals Inc.	3b307aea-5a68-4c82-959a-cda4ffbd0a4a	2013-11-15	Warnings	Exact identifier application number: ANDA076154 ndc (product): 0378-8880 rxcui: 311372 spl id: 1392dd15-842c-4689-87ba-caafc0503bca spl set id: 3b307aea-5a68-4c82-959a-cda4ffbd0a4a unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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