FDA.reportPublic FDA data

NDC 0409-1985-03 - 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
0409-1985
Requested NDC
0409-1985-03
Package NDCs from labels
0409-1985-03, 0409-1985-30
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lorazepam Injection, USPREMEDYREPACK INC.2026-08-17HUMAN PRESCRIPTION DRUG LABEL
Lorazepam Injection, USPHospira, Inc.2026-07-10HUMAN PRESCRIPTION DRUG LABEL
Lorazepam - Physicians Total Care, Inc.Physicians Total Care, Inc.2010-06-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-1985-03Lorazepam1 mL in 1 CARTRIDGEINJECTION, SOLUTION127
0409-1985-30Lorazepam10 in 1 CARTONINJECTION, SOLUTION1027

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1985LORAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]27Current NDC, Legacy NDC, 2 package rows20231030_20140b19-846b-425f-b191-670e17809945.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1985-03ML - Milliliter0409-1985025f0ae2-3046-4f0f-882b-004d40d878f712020-04-20
0409-1985-05ML - Milliliter0409-1985f6640e90-2d4b-4e4f-b275-3503af7865be12012-07-24
0409-1985-10ML - Milliliter0409-1985b6658d9d-ff4c-47f2-8f97-62dcc7c4c00112022-06-06
0409-1985-30ML - Milliliter0409-1985fd13bb17-584a-4a11-9661-5fab9ea5369f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]11
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]11
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHLORAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]11
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLORAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]11
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHLORAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ALORAZEPAM INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]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 7 of 15 · 297 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 6DC9Q167V3
LorazepamLORAZEPAMRedPharm Drug, Inc.891b2c10-942f-0e4d-e053-2995a90af0282025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMPharmPak, Inc.b6e4d2c7-10c0-4d77-be7b-caa3d3b869972025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
Zilactin Early Relief Cold SoreBENZYL ALCOHOLASCENT CONSUMER PRODUCTS, INC42ef8bfa-c4d9-01cf-e063-6394a90ac88a2025-11-06WarningsExact identifier
unii: LKG8494WBH
Systane Complete PFPROPYLENE GLYCOL EMULSIONAlcon Laboratories, Inc.798ffdde-1dba-4a3f-a0b6-937f9e958cca2025-11-03WarningsExact identifier
unii: 6DC9Q167V3
Advanced Eye Relief Dry Eye RejuvenationGLYCERIN PROPYLENE GLYCOLBausch & Lomb Incorporated027969ee-64e4-4b08-bab7-c4cc8ed22f5f2025-10-23WarningsExact identifier
unii: 6DC9Q167V3
Walgreens Ultra LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4533-2061-e063-6394a90a6e732025-10-17WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
LorazepamLORAZEPAMPD-Rx Pharmaceuticals, Inc.1f79a5a1-0c40-45cf-8994-51f5ba3a59382025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMPD-Rx Pharmaceuticals, Inc.0681c8db-ff09-4258-a5e0-76a26b0ea0af2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMPD-Rx Pharmaceuticals, Inc.7afd9a59-3463-4eda-8cf3-ef90be05de3d2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMPD-Rx Pharmaceuticals, Inc.7999b9c3-6185-4e4e-a4c3-d5d33d6c31d62025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMAmerican Health Packaging45e31a87-a8db-4dda-b94b-83535b62e8e22025-09-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
Dry eye reliefPOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADERf8da3af5-9172-4023-be82-0fd5bd8916162025-09-12WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
Systane COMPLETEPROPYLENE GLYCOLAlcon Laboratories, Inc.2df0de02-a3e2-471a-9e10-040c3fba75fe2025-08-08WarningsExact identifier
unii: 6DC9Q167V3
Systane BalancePROPYLENE GLYCOLAlcon Laboratories, Inc.c7b1a03a-a5f2-409e-a34a-d6f166671de52025-08-07WarningsExact identifier
unii: 6DC9Q167V3
LorazepamLORAZEPAMPD-Rx Pharmaceuticals, Inc.08a30230-fc95-9025-e063-6394a90ae21b2025-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
SystanePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.1d679d0f-cec2-a644-79cd-079607254bb92025-07-30WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
Systane Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
LorazepamLORAZEPAMRising Pharma Holdings, Inc.386255e2-65aa-48ce-9eb1-246f1493cc142025-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L

Reported adverse events (FAERS/openFDA)#

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