NDC 68180-347 - 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: 68180-347
Package NDCs from labels: 68180-347-01
Manufacturer: Lupin Pharmaceuticals, Inc. | LUPIN LIMITED
Effective date: 2021-04-01
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Lorazepam - Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2021-04-01	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68180-347-01	Lorazepam	1 in 1 CARTON	SOLUTION, CONCENTRATE	1		5
68180-347-01	Lorazepam	30 mL in 1 BOTTLE, DROPPER	SOLUTION, CONCENTRATE	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-347	LORAZEPAM SOLUTION, CONCENTRATE [LUPIN PHARMACEUTICALS, INC.]	5	2 package rows	20240201_4f44ebe9-c94d-47cc-8933-ce02009d81a1.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 14 of 14 · 268 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	Hikma Pharmaceuticals USA Inc.	b79b38ee-c29d-4099-964f-000031f47f5a	2022-04-26	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: O26FZP769L
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	1c956cc1-9217-46e0-80a3-7c811163d3f1	2021-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: O26FZP769L
Lorazepam	LORAZEPAM	Civica, Inc.	5140798d-8571-41fb-84a4-e182aac3f64c	2021-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: O26FZP769L
12f08796-1f82-4c52-9432-8f826f861787			4f44ebe9-c94d-47cc-8933-ce02009d81a1	2021-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier spl id: 12f08796-1f82-4c52-9432-8f826f861787 spl set id: 4f44ebe9-c94d-47cc-8933-ce02009d81a1
Lorazepam	LORAZEPAM	Hikma Pharmaceuticals USA Inc.	5ff82103-cc57-4af9-9362-82a7c686271d	2021-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 311376 unii: O26FZP769L
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	e83ae439-3fa5-453f-9073-4bf8c797df47	2019-03-26	Warnings, Adverse reactions	Exact identifier unii: O26FZP769L
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	a4fa14be-cef1-4b4b-b099-abde92f15145	2019-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: O26FZP769L
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	08bd30b0-a1c1-4ec3-bb9c-b1d55ac59f75	2018-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: O26FZP769L

Reported adverse events (FAERS/openFDA)#

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