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 2 of 15 · 297 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
LorazepamLORAZEPAMANI Pharmaceuticals, Inc.787240e9-67b5-4af3-b16d-7cf314e3f2e32026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMHospira, Inc.20140b19-846b-425f-b191-670e178099452026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074243
ndc (package): 0409-1539-03
ndc (package): 0409-1985-03
ndc (package): 0409-1539-31
ndc (package): 0409-1985-30
ndc (product): 0409-1539
ndc (product): 0409-1985
ndc11 (package): 00409198503
rxcui: 763029
rxcui: 763028
spl id: 0280cc35-0696-4091-a000-2314f292feb2
spl set id: 20140b19-846b-425f-b191-670e17809945
unii: O26FZP769L
LorazepamLORAZEPAMREMEDYREPACK INC.d6364be4-056b-4ebe-83bc-3fc85e8f488c2026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMSt. Mary's Medical Park Pharmacy56093df3-10f6-e747-e063-6294a90a65642026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMSt. Mary's Medical Park Pharmacy569e8a5a-ddf7-ebbc-e063-6294a90ab7a42026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMREMEDYREPACK INC.b707ecb2-644c-4323-ab0e-7bc5929cd5602026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMUnit Dose Solutions, Inc.5519bba8-9eb7-a3e0-e063-6294a90afd942026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMUnit Dose Solutions, Inc.551a1b7f-d342-2c53-e063-6394a90a9a2a2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: LKG8494WBH
LorazepamLORAZEPAMREMEDYREPACK INC.0cd02e52-ead5-4b2a-9708-c7c4be7b79952026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMCoupler LLC54d72943-f8d1-5a78-e063-6294a90a059b2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMRedpharm Drug5407f327-3a22-8c15-e063-6294a90a31692026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
Visine Red Eye Total Comfort Multi-SymptomTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORMKenvue Brands LLC5747edef-7a87-41d7-9594-6c78508b9ba22026-06-11WarningsExact identifier
unii: B697894SGQ
LORAZEPAMLORAZEPAMREMEDYREPACK INC.7fa1a011-5e28-4b13-bcd2-5c5fc9b663b22026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LORAZEPAMLORAZEPAMBryant Ranch Prepack46af8e93-3169-408a-b4d8-b8498642801d2026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
VitaPhyte Redness Reliever Lubricant Eye DropsREDNESS RELIEVER LUBRICANT EYE DROPSGuangzhou Liyan Cosmetics Technology Co., Ltd.53d4e9b0-c9a0-797a-e063-6294a90ad0cf2026-06-04WarningsExact identifier
unii: B697894SGQ
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Savings Distributors LLC558178eb-1eec-af0f-e063-6394a90afad92026-06-01WarningsExact identifier
unii: B697894SGQ
LorazepamLORAZEPAMPreferred Pharmaceuticals Inc.4a50329b-b272-4164-bddf-0d6cea3d7a232026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
Blink Triple Care Preservative FreePOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated65e67990-78b7-4ce9-963b-6bed3a6bed072026-05-27WarningsExact identifier
unii: B697894SGQ

Reported adverse events (FAERS/openFDA)#

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