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 8 of 13 · 253 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ITCH XBENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDEBF ASCHER AND CO INC03c16d33-8f59-0184-e054-00144ff8d46c2024-12-05WarningsExact identifier
unii: LKG8494WBH
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.364924d3-fac3-4f4e-9b40-decd4ec482452024-12-03WarningsExact identifier
unii: LKG8494WBH
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.ea5b4a7f-d47d-4dbd-9288-c01329e387e52024-12-03WarningsExact identifier
unii: LKG8494WBH
Orajel Toothache RinseBENZYL ALCOHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.41709710-5392-3119-e054-00144ff88e882024-11-27WarningsExact identifier
unii: LKG8494WBH
LorazepamLORAZEPAMFresenius Kabi USA, LLCb2487467-a63f-48b5-b0de-3a6ce6672d502024-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
Meijer Pain Lidocaine Plus Relieving AnalgesicBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEMeijer Distribution, Incb7385140-3f63-4cbc-b557-de1d29d1ea362024-11-15WarningsExact identifier
unii: LKG8494WBH
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Kenvue Brands LLCa9a90de6-3172-4d34-984b-f4442f880e3d2024-11-13WarningsExact identifier
unii: B697894SGQ
Visine Dry Eye ReliefPOLYETHYLENE GLYCOL 400Kenvue Brands LLC2de7a41d-661d-495f-89b4-5690664a3a3d2024-11-13WarningsExact identifier
unii: B697894SGQ
Visine Dry Eye Relief Eye DropsPOLYETHYLENE GLYCOL 400Kenvue Brands LLCd9d3f000-3ce4-4ba2-a7fb-491b44eb3fa12024-11-13WarningsExact identifier
unii: B697894SGQ
Visine Dry Eye ReliefPOLYETHYLENE GLYCOL 400Kenvue Brands LLCa4c57620-778f-4434-9105-ead2f85c58842024-11-13WarningsExact identifier
unii: B697894SGQ
LorazepamLORAZEPAMNuCare Pharmaceuticals, Inc.503834f9-fa2e-5e23-e054-00144ff88e882024-11-13Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMA-S Medication Solutionsbe85b116-9f09-403a-8e0d-e77e344d3a9a2024-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMChartwell RX, LLC6b0619c5-b9e9-47e7-97b5-7e581e67cf5f2024-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMAsclemed USA, Inc.ebdf72f7-7462-4b83-81b4-c7988860c7282024-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: LKG8494WBH
LorazepamLORAZEPAMNuCare Pharmaceuticals,Inc.8fa33078-c379-41f5-e053-2995a90acced2024-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMNuCare Pharmaceuticals, Inc.4a66b854-4dc1-3746-e054-00144ff8d46c2024-10-08Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
Fast Freeze Lidocaine Roll-OnLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNatural Essentials, Inc.74b06366-5eb4-4eba-aa2b-2b672828294d2024-10-04WarningsExact identifier
unii: LKG8494WBH
CVS Health Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNATURAL ESSENTIALS, INC.1adb9b74-4a01-4461-b845-f3aedcb3f8102024-10-01WarningsExact identifier
unii: LKG8494WBH
231dbd3a-331c-6c8f-e063-6394a90abf65840a1d60-fe5b-4de3-9247-62185dd5b64f2024-09-27Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: 840a1d60-fe5b-4de3-9247-62185dd5b64f

Reported adverse events (FAERS/openFDA)#

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