NDC 0641-6044-01 - 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: 0641-6044
Requested NDC: 0641-6044-01
Package NDCs from labels: 0641-6044-01, 0641-6044-25
Manufacturer: REMEDYREPACK INC.
Effective date: 2024-06-07
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	REMEDYREPACK INC.	2024-06-07	HUMAN PRESCRIPTION DRUG LABEL
Lorazepam Injection, USP	Hikma Pharmaceuticals USA Inc.	2024-04-09	HUMAN PRESCRIPTION DRUG LABEL
Lorazepam - TYA Pharmaceuticals	TYA Pharmaceuticals	2011-11-15	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-6044-01	Lorazepam	1 mL in 1 VIAL	INJECTION	1		10
0641-6044-25	Lorazepam	25 in 1 CARTON	INJECTION	25		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6044	LORAZEPAM INJECTION [HIKMA PHARMACEUTICALS USA INC.]	10	Current NDC, Legacy NDC, 2 package rows	20240410_e9b54e42-04cf-4c62-90e1-36f7b31a4e81.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6044-01	ML - Milliliter	0641-6044	9c10d57c-be4d-4e5c-bd04-680c477d6ef8	1	2012-07-24
0641-6044-25	ML - Milliliter	0641-6044	6e34d5a1-9495-43ce-a1cb-9f6626a83af7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM INJECTION [TYA PHARMACEUTICALS]	2
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	2
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM INJECTION [TYA PHARMACEUTICALS]	2
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	LORAZEPAM INJECTION [TYA PHARMACEUTICALS]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	LORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LORAZEPAM INJECTION [TYA PHARMACEUTICALS]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LORAZEPAM INJECTION [TYA PHARMACEUTICALS]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	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 11 of 15 · 298 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	Bryant Ranch Prepack	aac672f9-0ba7-4852-b8a7-caac9e4b1e77	2024-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: O26FZP769L
Walgreens Lidocaine Plus Cream	BENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDE	Walgreens Company	e33e0097-31d6-8083-e053-2a95a90af5d2	2024-05-09	Warnings	Exact identifier unii: LKG8494WBH
Enviroclenz	BERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM	Deseret Biologicals, Inc.	92816bbe-96d6-45fc-9929-d3e6df394a33	2024-05-02	Warnings	Exact identifier unii: 6DC9Q167V3
Lorazepam	LORAZEPAM	Proficient Rx LP	e9052b38-3c9f-4c84-9a0d-98bd99b9ddfd	2024-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: O26FZP769L
HealthWise Lidocaine Plus Cream	BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	16f26249-b508-2c6e-e063-6394a90a265b	2024-04-25	Warnings	Exact identifier unii: LKG8494WBH
Visine Red Eye Hydrating Comfort Eye Drops	TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400	Navajo Manufacturing Company Inc.	a70751ff-a313-49a7-e053-2a95a90a5447	2024-04-15	Warnings	Exact identifier unii: B697894SGQ
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	e563594e-212c-4f31-92ea-294aeab45df3	2024-04-12	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: O26FZP769L
Lorazepam	LORAZEPAM	Hikma Pharmaceuticals USA Inc.	4084fa74-9fd2-45ef-9d56-27bfa31d4e46	2024-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: NDA018140 rxcui: 1665188 rxcui: 1665326 rxcui: 238101 rxcui: 238100 unii: O26FZP769L
Lorazepam	LORAZEPAM	Hikma Pharmaceuticals USA Inc.	e9b54e42-04cf-4c62-90e1-36f7b31a4e81	2024-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: NDA018140 ndc (package): 0641-6046-10 ndc (package): 0641-6045-01 ndc (package): 0641-6047-10 ndc (package): 0641-6044-01 ndc (package): 0641-6044-25 ndc (package): 0641-6046-01 ndc (package): 0641-6047-01 ndc (package): 0641-6045-25 ndc (product): 0641-6045 ndc (product): 0641-6047 ndc (product): 0641-6044 ndc (product): 0641-6046 ndc11 (package): 00641604401 rxcui: 1665188 rxcui: 1665326 rxcui: 238101 rxcui: 238100 spl id: 7c73dbc6-2623-4443-9b05-97dec7a0be2e spl set id: e9b54e42-04cf-4c62-90e1-36f7b31a4e81 unii: O26FZP769L
Lorazepam	LORAZEPAM	Bryant Ranch Prepack	ba34ddd2-9a47-48bf-8e55-f05e9085e5a8	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: O26FZP769L
Lorazepam	LORAZEPAM	Bryant Ranch Prepack	8e3d44fb-24b7-4552-9e95-de3bf871a88b	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: O26FZP769L
Envirotox	TRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM.	BioActive Nutritional, Inc.	2b5cfdba-cf4d-4eb0-8c60-20eac6922663	2024-03-26	Warnings	Exact identifier unii: 6DC9Q167V3
Lorazepam	LORAZEPAM	International Medication Systems, Limited	7dda070d-7809-46c4-8592-eb4e4c509707	2024-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 238100 unii: O26FZP769L
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	82f79757-69f0-4a37-93a6-55b66ae86ad7	2024-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: O26FZP769L
LORAZEPAM	LORAZEPAM	A-S Medication Solutions	8602cef8-167e-4a8c-b10f-fc3295a3abcc	2024-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: O26FZP769L
Visine Red Eye Hydrating Comfort, CVP	TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400 SOLUTION/ DROPS	Lil' Drug Store Products, Inc.	0f50bcc8-3658-8c2c-e063-6294a90a8e13	2024-01-19	Warnings	Exact identifier unii: B697894SGQ
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	973eff80-b2cd-42ca-8e88-e0151e691e59	2024-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: O26FZP769L
Lorazepam	LORAZEPAM	Clinical Solutions Wholesale, LLC	fdc11b95-2233-42b4-b5f3-9390b5e9e1b2	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: O26FZP769L
Discount Drug Mart Eye Drops Multi-Symptom Relief	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	Discount Drug Mart, Inc.	318dc92a-0707-d6a4-e063-6294a90ab78a	2024-01-01	Warnings	Exact identifier unii: B697894SGQ
Harris Teeter Ultra Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Harris Teeter, LLC.	31ac6883-ffc6-39de-e063-6294a90a52dd	2024-01-01	Warnings	Exact identifier unii: 6DC9Q167V3 unii: B697894SGQ

Reported adverse events (FAERS/openFDA)#

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