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 7 of 11 · 214 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Orajel Toothache RinseBENZYL ALCOHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.41709710-5392-3119-e054-00144ff88e882024-11-27WarningsExact identifier
unii: LKG8494WBH
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
Meijer Pain Lidocaine Plus Relieving AnalgesicBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEMeijer Distribution, Incb7385140-3f63-4cbc-b557-de1d29d1ea362024-11-15WarningsExact identifier
unii: LKG8494WBH
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: LKG8494WBH
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
Enoxiluv KitENOXAPARIN SODIUM, ISOPROPYL ALCOHOLAsclemed USA, Inc.e8855fae-f70d-4099-969e-a1d9f29292592024-10-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854235
Fast Freeze Lidocaine Roll-OnLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNatural Essentials, Inc.74b06366-5eb4-4eba-aa2b-2b672828294d2024-10-04WarningsExact identifier
unii: LKG8494WBH
CVS Health Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNATURAL ESSENTIALS, INC.1adb9b74-4a01-4461-b845-f3aedcb3f8102024-10-01WarningsExact identifier
unii: LKG8494WBH
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
IvarestZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDEBlistex Inc6f68cbbb-6269-4bb3-8cc9-50b146703b422024-07-09WarningsExact identifier
unii: LKG8494WBH
Enoxaparin SodiumENOXAPARIN SODIUMNorthStar RxLLC014c6710-f2c4-fd1e-e063-6394a90ae5252024-06-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854245
rxcui: 854248
rxcui: 854241
rxcui: 854252
rxcui: 854238
rxcui: 854228
rxcui: 854235
unii: 8NZ41MIK1O
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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