NDC 80425-0465-01 - LORAZEPAM

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: 80425-0465
Requested NDC: 80425-0465-01
Package NDCs from labels: 80425-0465-2, 80425-0465-1, 80425-0465-3, 80425-0465-01
Manufacturer: Advanced Rx of Tennessee, LLC
Effective date: 2024-12-28
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
LORAZEPAM - Advanced Rx of Tennessee, LLC	Advanced Rx of Tennessee, LLC	2024-12-28	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80425-0465-1	LORAZEPAM	30 in 1 BOTTLE	TABLET	30	1
80425-0465-2	LORAZEPAM	60 in 1 BOTTLE	TABLET	60	1
80425-0465-3	LORAZEPAM	90 in 1 BOTTLE	TABLET	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0465	LORAZEPAM TABLET [ADVANCED RX OF TENNESSEE, LLC]	1	Current NDC, 3 package rows	20241229_2a57e549-390b-5482-e063-6394a90aeb3b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0465-1	EA - Each	80425-0465	c9a5c15d-634e-4151-9f9d-ac45e6e2ff55	1	2025-02-10
80425-0465-2	EA - Each	80425-0465	f1a7c740-4286-4317-b809-d7bdd589bada	1	2025-02-10
80425-0465-3	EA - Each	80425-0465	d0a1df18-ba50-4e23-81b5-85ef0801a801	1	2025-02-10

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 6 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	a4fa14be-cef1-4b4b-b099-abde92f15145	2019-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA203572 rxcui: 197900 unii: O26FZP769L
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	08bd30b0-a1c1-4ec3-bb9c-b1d55ac59f75	2018-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 197902 unii: O26FZP769L

Reported adverse events (FAERS/openFDA)#

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