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 11 of 11 · 214 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Ivy-Dry SuperBENZYL ALCOHOL, CAMPHOR, MENTHOLIvy-Dry, Inc.4792a667-2378-4b3d-968d-9efb1866792f2017-12-27WarningsExact identifier
unii: LKG8494WBH
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: LKG8494WBH
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
cf63553d-cb67-44c0-8c5f-44683f9a30acafec67a9-ae16-4f48-bc0b-5331835e8aa22009-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: cf63553d-cb67-44c0-8c5f-44683f9a30ac
spl set id: afec67a9-ae16-4f48-bc0b-5331835e8aa2

Reported adverse events (FAERS/openFDA)#

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