FDA.reportPublic FDA data

Lovenox

Product NDC
0075-8022
11-digit product format
000758022
Labeler code
0075
Product ID
0075-8022_006561fa-e16d-4129-9dde-89c109b51d8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
enoxaparin sodium
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Sanofi-Aventis U.S. LLC
Application
NDA020164
Marketing category
NDA
Marketing start
1993-03-29
Substance
ENOXAPARIN SODIUM
Active strength
120 mg/.8mL
Pharmacologic classes
Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lovenox
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENOXAPARIN SODIUM120 mg/.8mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8NZ41MIK1O
Rxcui854228, 854232, 854235, 854236, 854238, 854239, 854241, 854242, 854245, 854247, 854248, 854249, 854252, 854253, 854255, 854256

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33a7d2c8-f5cf-4d97-8510-92190c5e0f12Product name720240606

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0075-8022-01Lovenox0.8 mL in 1 SYRINGEINJECTION0.815
0075-8022-10Lovenox1 in 1 CELLO PACKINJECTION115
0075-8022-10Lovenox10 in 1 CARTONINJECTION1015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0075-8022-01ML - Milliliter0075-802212f92752-6122-45e1-823f-e3c4de43e0d512013-11-04
0075-8022-10ML - Milliliter0075-8022a8453bbf-8d1e-4d4c-aba0-04eab913ca4512013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
enoxaparin sodiumACTIVE INGREDIENT8NZ41MIK1OLOVENOX (ENOXAPARIN SODIUM) INJECTION [SANOFI-AVENTIS U.S. LLC]3
enoxaparinACTIVE MOIETYE47C0NF7LVLOVENOX (ENOXAPARIN SODIUM) INJECTION [SANOFI-AVENTIS U.S. LLC]3
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHLOVENOX (ENOXAPARIN SODIUM) INJECTION [SANOFI-AVENTIS U.S. LLC]3
waterINACTIVE INGREDIENT059QF0KO0RLOVENOX (ENOXAPARIN SODIUM) INJECTION [SANOFI-AVENTIS U.S. LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0075-8022LOVENOX (ENOXAPARIN SODIUM) INJECTION [SANOFI-AVENTIS U.S. LLC]10Current NDC, Legacy NDC, 3 package rows20220412_de6fb917-a94a-41ea-9d7d-937d4080ffcd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854248enoxaparin sodium 100 MG in 1 ML Prefilled SyringePSNde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854255enoxaparin sodium 100 MG/ML Injectable SolutionPSNde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854245enoxaparin sodium 120 MG in 0.8 ML Prefilled SyringePSNde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854252enoxaparin sodium 150 MG in 1 ML Prefilled SyringePSNde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854228enoxaparin sodium 30 MG in 0.3 ML Prefilled SyringePSNde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSNde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854238enoxaparin sodium 60 MG in 0.6 ML Prefilled SyringePSNde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854241enoxaparin sodium 80 MG in 0.8 ML Prefilled SyringePSNde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854249Lovenox 100 MG in 1 ML Prefilled SyringePSNde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854256Lovenox 100 MG/ML Injectable SolutionPSNde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854247Lovenox 120 MG in 0.8 ML Prefilled SyringePSNde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854253Lovenox 150 MG in 1 ML Prefilled SyringePSNde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854232Lovenox 30 MG in 0.3 mL Prefilled SyringePSNde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854236Lovenox 40 MG in 0.4 mL Prefilled SyringePSNde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854239Lovenox 60 MG in 0.6 mL Prefilled SyringePSNde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854242Lovenox 80 MG in 0.8 ML Prefilled SyringePSNde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542320.3 ML enoxaparin sodium 100 MG/ML Prefilled Syringe [Lovenox]SBDde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542360.4 ML enoxaparin sodium 100 MG/ML Prefilled Syringe [Lovenox]SBDde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542390.6 ML enoxaparin sodium 100 MG/ML Prefilled Syringe [Lovenox]SBDde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542420.8 ML enoxaparin sodium 100 MG/ML Prefilled Syringe [Lovenox]SBDde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542470.8 ML enoxaparin sodium 150 MG/ML Prefilled Syringe [Lovenox]SBDde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542491 ML enoxaparin sodium 100 MG/ML Prefilled Syringe [Lovenox]SBDde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542531 ML enoxaparin sodium 150 MG/ML Prefilled Syringe [Lovenox]SBDde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854256enoxaparin sodium 100 MG/ML Injectable Solution [Lovenox]SBDde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542280.3 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542380.6 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542410.8 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542450.8 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCDde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542481 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542521 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCDde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854255enoxaparin sodium 100 MG/ML Injectable SolutionSCDde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542280.3 ML ENX sodium 100 MG/ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542320.3 ML ENX sodium 100 MG/ML Prefilled Syringe [Lovenox]SYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542320.3 ML Lovenox 100 MG/ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542360.4 ML ENX sodium 100 MG/ML Prefilled Syringe [Lovenox]SYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542360.4 ML Lovenox 100 MG/ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542380.6 ML ENX sodium 100 MG/ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542390.6 ML ENX sodium 100 MG/ML Prefilled Syringe [Lovenox]SYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542390.6 ML Lovenox 100 MG/ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542410.8 ML ENX sodium 100 MG/ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542420.8 ML ENX sodium 100 MG/ML Prefilled Syringe [Lovenox]SYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542450.8 ML ENX sodium 150 MG/ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542470.8 ML ENX sodium 150 MG/ML Prefilled Syringe [Lovenox]SYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542420.8 ML Lovenox 100 MG/ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542470.8 ML Lovenox 150 MG/ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542481 ML ENX sodium 100 MG/ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542491 ML ENX sodium 100 MG/ML Prefilled Syringe [Lovenox]SYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542521 ML ENX sodium 150 MG/ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542531 ML ENX sodium 150 MG/ML Prefilled Syringe [Lovenox]SYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542491 ML Lovenox 100 MG/ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
8542531 ML Lovenox 150 MG/ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854252enoxaparin 150 MG per 1 ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854248enoxaparin sodium 100 MG per 1 ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854245enoxaparin sodium 120 MG per 0.8 ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854228enoxaparin sodium 30 MG per 0.3 ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854238enoxaparin sodium 60 MG per 0.6 ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854241enoxaparin sodium 80 MG per 0.8 ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854255ENX sodium 100 MG/ML Injectable SolutionSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854256ENX sodium 100 MG/ML Injectable Solution [Lovenox]SYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854249Lovenox 100 MG per 1 ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854256Lovenox 100 MG/ML Injectable SolutionSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854247Lovenox 120 MG per 0.8 ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854253Lovenox 150 MG per 1 ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854232Lovenox 30 MG per 0.3 ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854256Lovenox 300 MG per 3 ML Injectable SolutionSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854236Lovenox 40 MG per 0.4 ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854239Lovenox 60 MG per 0.6 ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15
854242Lovenox 80 MG per 0.8 ML Prefilled SyringeSYde6fb917-a94a-41ea-9d7d-937d4080ffcd15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0075-8022-01000758022010.8 mL in 1 SYRINGE0.8 mlHistorical
0075-8022-100007580221010 CELLO PACK in 1 CARTON (0075-8022-10) / 1 SYRINGE in 1 CELLO PACK / .8 mL in 1 SYRINGE (0075-8022-01) 10 cello pack1993-03-290000-00-00NoNoCurrent