FDA.reportPublic FDA data

NDC 76329-8261-01 - 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
76329-8261
Requested NDC
76329-8261-01
Package NDCs from labels
76329-8261-1, 76329-8261-01
Manufacturer
REMEDYREPACK INC.
Effective date
2024-03-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lorazepam - REMEDYREPACK INC.REMEDYREPACK INC.2024-03-14HUMAN PRESCRIPTION DRUG LABEL
Lorazepam - International Medication Systems, LimitedInternational Medication Systems, Limited2024-03-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76329-8261-1Lorazepam10 mL in 1 VIALINJECTION1013
76329-8261-1Lorazepam10 in 1 CARTONINJECTION1013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76329-8261LORAZEPAM INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]13Current NDC, Legacy NDC, 2 package rows20240306_7dda070d-7809-46c4-8592-eb4e4c509707.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76329-8261-1ML - Milliliter76329-8261434a2601-7460-488b-b472-386a13aa934312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LorazepamACTIVE INGREDIENTO26FZP769LLORAZEPAM INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]2
LorazepamACTIVE MOIETYO26FZP769LLORAZEPAM INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]2
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHLORAZEPAM INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]2
Polyethylene glycol 400INACTIVE INGREDIENTB697894SGQLORAZEPAM INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]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 3 of 13 · 253 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Retaine Ultra PFPOLYETHYLENE GLYCOLOCuSOFT LLCa5aaaf06-772d-44d3-8601-f978ddc48ad72026-04-13WarningsExact identifier
unii: B697894SGQ
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: B697894SGQ
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: B697894SGQ
BLINK TRIPLE CAREPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporateda2b34eb0-001b-4f42-a8cc-c2a0150fafcc2026-03-20WarningsExact identifier
unii: B697894SGQ
LorazepamLORAZEPAMFresenius Kabi USA, LLC462a13da-259a-40e7-bd5b-f7f42ae025b72026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
Leader Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Healthd7f011a2-05ba-47c3-9519-d31602e105c72026-03-12WarningsExact identifier
unii: B697894SGQ
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: B697894SGQ
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: B697894SGQ
Walgreens Unscented Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLWalgreen Co.41eadb4f-2ca5-42a1-e063-6294a90ab4e22026-03-04WarningsExact identifier
unii: LKG8494WBH
LORAZEPAMLORAZEPAMPD-Rx Pharmaceuticals, Inc.0418ad09-3069-4381-9a8f-e41b234fdac62026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
unii: B697894SGQ
LorazepamLORAZEPAMA-S Medication Solutions8361519b-be1a-4542-a782-d7cdfa153e862026-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMREMEDYREPACK INC.a0a33933-f697-4d3b-ba99-8a995a4b6c6b2026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LORAZEPAMLORAZEPAMDIRECT RX4832f02d-289c-2fe6-e054-00144ff8d46c2026-01-08Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
Lubricant Eye Drops SolutionPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAvPAKf5743b38-e3d2-a065-e053-2995a90a4b9a2026-01-08WarningsExact identifier
unii: B697894SGQ
Value Health by Prodose Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Prodose, Inc.3fafa362-a8a6-3f91-e063-6394a90a98b32025-12-31WarningsExact identifier
unii: B697894SGQ
Signature Care Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLBetter Living Brands LLC6f1f4f58-3208-4b06-9afb-c4beeed093142025-12-30WarningsExact identifier
unii: B697894SGQ
Target Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTarget Corporation6c449374-8847-4c4a-9073-1951ff31d4042025-12-30WarningsExact identifier
unii: B697894SGQ
Target Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTarget Corporationddc15dac-fbd8-42fa-80db-79f49fc6b9eb2025-12-30WarningsExact identifier
unii: B697894SGQ
CVS Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDECVS Pharmacy, Inc.f74a2fca-902c-f68a-e053-6394a90abb882025-12-30WarningsExact identifier
unii: B697894SGQ

Reported adverse events (FAERS/openFDA)#

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