FDA.reportPublic FDA data

NDC 0641-6049-01 - 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
0641-6049
Requested NDC
0641-6049-01
Package NDCs from labels
0641-6049-01, 0641-6049-25
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2024-04-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lorazepam Injection, USPHikma Pharmaceuticals USA Inc.2024-04-10HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6049-01Lorazepam1 mL in 1 VIALINJECTION19
0641-6049-25Lorazepam25 in 1 CARTONINJECTION259

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6049LORAZEPAM INJECTION [HIKMA PHARMACEUTICALS USA INC.]9Current NDC, Legacy NDC, 2 package rows20240411_4084fa74-9fd2-45ef-9d56-27bfa31d4e46.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6049-01ML - Milliliter0641-604940bb8812-10d0-4a32-8101-4b725f6aa86112012-07-24
0641-6049-25ML - Milliliter0641-60491c6ef2a8-11fc-4351-ac12-c2768d14491912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHLORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1

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 1 of 15 · 300 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LorazepamLORAZEPAMClinical Solutions Wholesale, LLCc0810422-b732-4c04-97d8-c1521c401ef42026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMREMEDYREPACK INC.86630bdd-13ad-4ab5-9e94-fcf2ea2113e12026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
0.9% Benzyl Alcohol Solution (Laboratory Use Only)0.9% BENZYL ALCOHOL SOLUTION (LABORATORY USE ONLY)Guangzhou Huanmei Cosmetics Co., Ltd5976bde6-0999-ffc4-e063-6394a90aadcf2026-08-20WarningsExact identifier
unii: LKG8494WBH
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
LorazepamLORAZEPAMREMEDYREPACK INC.5a02c97d-637d-43f7-803c-afe4381ccc592026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: B697894SGQ
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
unii: 6DC9Q167V3
LorazepamLORAZEPAMREMEDYREPACK INC.6c5356b1-c199-49ad-bb00-fd67c6691f742026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
LorazepamLORAZEPAMREMEDYREPACK INC.ed37d304-04cf-43ec-a58d-d72002ff889b2026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LORAZEPAMLORAZEPAMPreferred Pharmaceuticals Inc.903351ae-1bb0-4ac0-8430-df24cf2eee762026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMREMEDYREPACK INC.be9f8bda-1cd9-40a6-a4da-b5961389fb5b2026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
unii: LKG8494WBH
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
unii: 6DC9Q167V3
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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