NDC 68071-3121-06 - 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: 68071-3121
Requested NDC: 68071-3121-06
Package NDCs from labels: 68071-3121-6, 68071-3121-06
Manufacturer: NuCare Pharmaceuticals, Inc. | .
Effective date: 2024-07-19
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Lorazepam Tablets, USP CIV Rx only	NuCare Pharmaceuticals, Inc. \| .	2024-07-19	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-07-03	Lorazepam Tablets, USP CIV Rx only
2023-01-30	Lorazepam Tablets, USP CIV Rx only
2021-02-11	Lorazepam Tablets, USP CIV Rx only
2021-01-29	Lorazepam Tablets, USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3121-6	Lorazepam	6 in 1 BOTTLE	TABLET	6		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3121	LORAZEPAM TABLET [NUCARE PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20240720_4ab77192-8fe9-2965-e054-00144ff88e88.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 6 · 102 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	Clinical Solutions Wholesale, LLC	fdc11b95-2233-42b4-b5f3-9390b5e9e1b2	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA078203 rxcui: 197901 rxcui: 197900 rxcui: 197902 unii: O26FZP769L
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	0ce02d7d-d855-c73f-e063-6294a90abe93	2023-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 197900 unii: O26FZP769L
Lorazepam	LORAZEPAM	Leading Pharma, LLC	5ca13415-4b77-4131-a9d2-6db26bc49167	2023-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA078203 ndc (product): 69315-904 rxcui: 197901 rxcui: 197900 rxcui: 197902 spl id: 40249bb6-0d25-4b2f-aa4b-85c15af6bf8b spl set id: 5ca13415-4b77-4131-a9d2-6db26bc49167 unii: O26FZP769L
Lorazepam	LORAZEPAM	Asclemed USA, Inc.	91da80c8-3162-43f0-b53e-897070b26a54	2023-11-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA078203 rxcui: 197900 unii: O26FZP769L
LORAZEPAM	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	247110f2-5468-4593-8d86-41f8c869e03d	2023-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 197901 unii: O26FZP769L
Lorazepam	LORAZEPAM	Chartwell RX, LLC	e075c78d-f0c6-4380-b769-bb8833d23ba5	2023-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: O26FZP769L
LORAZEPAM	LORAZEPAM	A-S Medication Solutions	823b1d71-a510-4d34-8015-60b55af23d78	2023-08-24	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 197901 unii: O26FZP769L
Lorazepam	LORAZEPAM	Amneal Pharmaceuticals LLC	bf265c2e-ab2f-42e5-96cf-3998eb5a644d	2023-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: O26FZP769L
Lorazepam	LORAZEPAM	SUN PHARMACEUTICAL INDUSTRIES INC	0c1caa9c-9ef1-459c-86c3-adb939130a9f	2023-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 197901 rxcui: 197900 rxcui: 197902 unii: O26FZP769L
Lorazepam	LORAZEPAM	Teva Pharmaceuticals USA, Inc.	1bf22e97-9425-484d-bac6-519c6bae6a37	2023-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 197901 rxcui: 197900 rxcui: 197902 unii: O26FZP769L
Lorazepam	LORAZEPAM	Proficient Rx LP	a407d3fe-ff0f-45b0-8a1e-c7a2a11c5569	2023-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 197900 unii: O26FZP769L
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	8df3eed3-c936-4772-ab08-574c54dd8bf5	2023-01-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA078203 rxcui: 197901 unii: O26FZP769L
Lorazepam	LORAZEPAM	Pharmaceutical Associates, Inc.	711b60a3-028d-41d4-aa17-8f976e6df23e	2022-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: O26FZP769L
Lorazepam	LORAZEPAM	Proficient Rx LP	73bf2b31-5c7e-4b3a-9e97-8304931510b0	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA078203 rxcui: 197901 unii: O26FZP769L
Lorazepam	LORAZEPAM	Proficient Rx LP	5b78f7af-0ad8-4fa1-a8c0-9308fe8d9b3a	2022-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 197900 unii: O26FZP769L
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 rxcui: 197902 unii: O26FZP769L
Lorazepam	LORAZEPAM	Civica, Inc.	5140798d-8571-41fb-84a4-e182aac3f64c	2021-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: O26FZP769L
Lorazepam	LORAZEPAM	Hikma Pharmaceuticals USA Inc.	5ff82103-cc57-4af9-9362-82a7c686271d	2021-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: O26FZP769L
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	e83ae439-3fa5-453f-9073-4bf8c797df47	2019-03-26	Warnings, Adverse reactions	Exact identifier application number: ANDA078203 rxcui: 197900 unii: O26FZP769L

Reported adverse events (FAERS/openFDA)#

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