NDC 0641-6207-01 - 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: 0641-6207
Requested NDC: 0641-6207-01
Package NDCs from labels: 0641-6207-01, 0641-6207-25
Manufacturer: Hikma Pharmaceuticals USA Inc.
Effective date: 2022-04-26
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Lorazepam Injection, USP	Hikma Pharmaceuticals USA Inc.	2022-04-26	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-6207-01	Lorazepam	1 mL in 1 VIAL	INJECTION	1		4
0641-6207-25	Lorazepam	25 in 1 CARTON	INJECTION	25		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6207	LORAZEPAM INJECTION [HIKMA PHARMACEUTICALS USA INC.]	4	Current NDC, Legacy NDC, 2 package rows	20220427_b79b38ee-c29d-4099-964f-000031f47f5a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6207-01	ML - Milliliter	0641-6207	bae05ac9-ffc5-4459-a3da-fa82475ca753	1	2018-01-12
0641-6207-25	ML - Milliliter	0641-6207	3284cc80-dd3b-4918-8594-fffbc9398e33	1	2018-01-12

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 15 of 15 · 296 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	Teva Pharmaceuticals USA, Inc.	1bf22e97-9425-484d-bac6-519c6bae6a37	2023-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: O26FZP769L
Lorazepam	LORAZEPAM	Proficient Rx LP	a407d3fe-ff0f-45b0-8a1e-c7a2a11c5569	2023-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: O26FZP769L
Petrochemical Detox	CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SYMPHYTUM OFFICINALE, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, CADMIUM SULPHURATUM, GELSEMIUM SEMPERVIRENS, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PLATINUM METALLICUM, LATRODECTUS MACTANS	Deseret Biologicals, Inc.	b38b492a-cf45-4aa2-ba7e-4573d2c4ebe5	2023-01-12	Warnings	Exact identifier unii: 6DC9Q167V3
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	8df3eed3-c936-4772-ab08-574c54dd8bf5	2023-01-04	Boxed warning, Warnings, Adverse reactions	Exact identifier 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 unii: O26FZP769L
Lorazepam	LORAZEPAM	Proficient Rx LP	5b78f7af-0ad8-4fa1-a8c0-9308fe8d9b3a	2022-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: O26FZP769L
Lorazepam	LORAZEPAM	Hikma Pharmaceuticals USA Inc.	b79b38ee-c29d-4099-964f-000031f47f5a	2022-04-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: NDA018140 ndc (package): 0641-6207-01 ndc (package): 0641-6207-25 ndc (product): 0641-6207 ndc11 (package): 00641620701 rxcui: 238100 spl id: 4f2988b1-2854-4051-962f-07cc925608ab spl set id: b79b38ee-c29d-4099-964f-000031f47f5a 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 application number: NDA018140 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 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
Ivy-Dry Super	BENZYL ALCOHOL, CAMPHOR, MENTHOL	Ivy-Dry, Inc.	4792a667-2378-4b3d-968d-9efb1866792f	2017-12-27	Warnings	Exact identifier unii: LKG8494WBH
Homeoplex D	GLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,	Supplement Clinic, LLC.	cd6b48ab-3566-484d-8deb-15ef6f8e7e8f	2017-11-01	Warnings	Exact identifier unii: LKG8494WBH

Reported adverse events (FAERS/openFDA)#

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