FDA.reportPublic FDA data

NDC 51079-417-56 - 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
51079-417
Requested NDC
51079-417-56
Package NDCs from labels
51079-417-01, 51079-417-20, 51079-417-56
Manufacturer
Cardinal Health
Effective date
2019-06-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lorazepam - Cardinal HealthCardinal Health2019-06-17HUMAN PRESCRIPTION DRUG LABEL
Lorazepam - Mylan Institutional Inc.Mylan Institutional Inc.2018-12-27HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-417-01EA - Each51079-4174185b752-e84b-4220-bb90-9560d4a61b1612012-07-24
51079-417-20EA - Each51079-4173a36029a-a153-439c-901a-8016cb9786ac12012-07-24
51079-417-21EA - Each51079-417924624e3-d524-4408-a0d9-e4feadf0a47412012-07-24
51079-417-56EA - Each51079-41773c19bb4-6448-49e4-8240-d3790517522912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [CARDINAL HEALTH]9
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [CARDINAL HEALTH]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [CARDINAL HEALTH]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORAZEPAM TABLET [CARDINAL HEALTH]9
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [CARDINAL HEALTH]9
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UILORAZEPAM TABLET [CARDINAL HEALTH]9
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UILORAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3

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 6 · 107 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
LorazepamLORAZEPAMREMEDYREPACK INC.5a02c97d-637d-43f7-803c-afe4381ccc592026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMREMEDYREPACK INC.6c5356b1-c199-49ad-bb00-fd67c6691f742026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
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
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
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
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
LORAZEPAMLORAZEPAMREMEDYREPACK INC.7fa1a011-5e28-4b13-bcd2-5c5fc9b663b22026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMREMEDYREPACK INC.ac1f88c2-2cf2-47de-a612-946cd45030902026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L

Reported adverse events (FAERS/openFDA)#

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