FDA.reportPublic FDA data

NDC 0075-0621-01 - Lovenox

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
0075-0621
Requested NDC
0075-0621-01
Package NDCs from labels
0075-0621-01, 0075-0621-60
Manufacturer
Sanofi-Aventis U.S. LLC | Sanofi-Aventis Singapore Pte. Ltd. | Patheon Manufacturing Services LLC | Sanofi-Aventis Deutschland GmbH | Sanofi Winthrop Industrie
Effective date
2026-05-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LovenoxSanofi-Aventis U.S. LLC | Sanofi-Aventis Singapore Pte. Ltd. | Patheon Manufacturing Services LLC | Sanofi-Aventis Deutschland GmbH | Sanofi Winthrop Industrie2026-05-28HUMAN PRESCRIPTION DRUG LABEL
Lovenox - Physicians Total Care, Inc.Physicians Total Care, Inc.2009-12-30HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2025-02-07These highlights do not include all the information needed to use LOVENOX safely and effectively. See full prescribing information for LOVENOX. LOVENOX (enoxaparin sodium) injection, for subcutaneous and intravenous use Initial U.S. Approval: 1993
2025-02-07These highlights do not include all the information needed to use LOVENOX safely and effectively. See full prescribing information for LOVENOX. LOVENOX (enoxaparin sodium) injection, for subcutaneous and intravenous use Initial U.S. Approval: 1993
2025-01-30These highlights do not include all the information needed to use LOVENOX safely and effectively. See full prescribing information for LOVENOX. LOVENOX (enoxaparin sodium) injection, for subcutaneous and intravenous use Initial U.S. Approval: 1993
2025-01-30These highlights do not include all the information needed to use LOVENOX safely and effectively. See full prescribing information for LOVENOX. LOVENOX (enoxaparin sodium) injection, for subcutaneous and intravenous use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0075-0621-01Lovenox0.6 mL in 1 SYRINGEINJECTION0.633
0075-0621-01Lovenox1 in 1 CELLO PACKINJECTION133
0075-0621-60Lovenox10 in 1 CARTONINJECTION1033

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0075-0621LOVENOX (ENOXAPARIN SODIUM) INJECTION [SANOFI-AVENTIS U.S. LLC]27Current NDC, Legacy NDC, 3 package rows20250210_5017a927-2a24-4f27-89f9-27c805bf7d59.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0075-0621-60ML - Milliliter0075-0621c828c607-7484-488e-bb92-e99a78d49e7f12012-07-24
0075-0621-61ML - Milliliter0075-0621fabadc65-bf6b-42f1-9097-dcad3c5578e712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
enoxaparin sodiumACTIVE INGREDIENT8NZ41MIK1OLOVENOX (ENOXAPARIN SODIUM) INJECTION [SANOFI-AVENTIS U.S. LLC]16
enoxaparinACTIVE MOIETYE47C0NF7LVLOVENOX (ENOXAPARIN SODIUM) INJECTION [SANOFI-AVENTIS U.S. LLC]16
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHLOVENOX (ENOXAPARIN SODIUM) INJECTION [SANOFI-AVENTIS U.S. LLC]16
waterINACTIVE INGREDIENT059QF0KO0RLOVENOX (ENOXAPARIN SODIUM) INJECTION [SANOFI-AVENTIS U.S. LLC]16
ENOXAPARIN SODIUMACTIVE INGREDIENT8NZ41MIK1OLOVENOX (ENOXAPARIN SODIUM) INJECTION [PHYSICIANS TOTAL CARE, INC.]1
ENOXAPARINACTIVE MOIETYE47C0NF7LVLOVENOX (ENOXAPARIN SODIUM) INJECTION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RLOVENOX (ENOXAPARIN SODIUM) INJECTION [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 10 of 11 · 214 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: 059QF0KO0R
Enoxaparin SodiumENOXAPARIN SODIUMBluePoint Laboratories9e2875df-0f0c-46ec-990f-69108f383f582023-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854255
rxcui: 854245
rxcui: 854248
rxcui: 854241
rxcui: 854252
rxcui: 854238
rxcui: 854228
rxcui: 854235
unii: 8NZ41MIK1O
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
Enoxaparin SodiumENOXAPARIN SODIUMItalfarmaco SpAb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92022-11-05Exact identifier
rxcui: 854245
rxcui: 854248
rxcui: 854241
rxcui: 854252
rxcui: 854238
rxcui: 854228
rxcui: 854235
unii: 8NZ41MIK1O
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Enoxaparin SodiumENOXAPARIN SODIUMAmphastar Pharmaceuticals, Inc.3e6bf2b3-9339-4104-bda3-ad86a19497032022-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854255
rxcui: 854245
rxcui: 854248
rxcui: 854241
rxcui: 854252
rxcui: 854238
rxcui: 854228
rxcui: 854235
unii: 8NZ41MIK1O
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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