FDA.reportPublic FDA data

NDC 0075-0622-01 - 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
0075-0622
Requested NDC
0075-0622-01
Package NDCs from labels
0075-0622-01, 0075-0622-80
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
0075-0622-01Lovenox0.8 mL in 1 SYRINGEINJECTION0.833
0075-0622-01Lovenox1 in 1 CELLO PACKINJECTION133
0075-0622-80Lovenox10 in 1 CARTONINJECTION1033

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0075-0622LOVENOX (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
0075-0622-80ML - Milliliter0075-06223e341120-ccd6-48bf-ac43-f3c2199b49c412012-07-24
0075-0622-81ML - Milliliter0075-062254c85a59-1998-4beb-bce6-925fc2b8c45112012-07-24

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 3 of 11 · 214 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Enoxaparin SodiumENOXAPARIN SODIUMFresenius Kabi USA, LLC21b095d1-5ade-43e9-9114-30fbfb2331c92026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA020164
rxcui: 854255
rxcui: 854245
rxcui: 854248
rxcui: 854241
rxcui: 854252
rxcui: 854238
rxcui: 854228
rxcui: 854235
unii: 8NZ41MIK1O
Enoxaparin SodiumENOXAPARIN SODIUMFresenius Kabi USA, LLC066f27ec-352c-4051-ba29-248e292690db2026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA020164
rxcui: 854255
rxcui: 854245
rxcui: 854248
rxcui: 854241
rxcui: 854252
rxcui: 854238
rxcui: 854228
rxcui: 854235
unii: 8NZ41MIK1O
ENOXAPARIN SODIUMENOXAPARIN SODIUMGland Pharma Limited65025e0d-eb54-4c4e-bd14-f294ce0389022026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854245
rxcui: 854248
rxcui: 854241
rxcui: 854252
rxcui: 854238
rxcui: 854228
rxcui: 854235
unii: 8NZ41MIK1O
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
enoxaparin sodiumENOXAPARIN SODIUMHebei Changshan Biochemical Pharmaceutical Co., Ltd.7fa78f8d-92d9-434a-8e26-b886ab0ae77f2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854245
rxcui: 854248
rxcui: 854241
rxcui: 854252
rxcui: 854238
rxcui: 854228
rxcui: 854235
unii: 8NZ41MIK1O
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Enoxaparin SodiumENOXAPARIN SODIUMMeitheal Pharmaceuticals Inc.b6fb85ab-1fe5-4dd3-a97f-adbed0674f672026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854245
rxcui: 854248
rxcui: 854241
rxcui: 854252
rxcui: 854238
rxcui: 854228
rxcui: 854235
unii: 8NZ41MIK1O
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: LKG8494WBH
Enoxaparin SodiumENOXAPARIN SODIUMMeitheal Pharmaceuticals Inc.adbba7bb-fa72-4cec-aa69-13965591a45d2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854245
rxcui: 854248
rxcui: 854241
rxcui: 854252
rxcui: 854238
rxcui: 854228
rxcui: 854235
unii: 8NZ41MIK1O
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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