FDA.reportPublic FDA data

Enoxaparin sodium

Product NDC
0955-1008
11-digit product format
009551008
Labeler code
0955
Product ID
0955-1008_48bacfb7-7152-45b1-a188-59c4a205f5b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
enoxaparin sodium
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Sanofi-Aventis U.S. LLC
Application
NDA020164
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2011-10-03
Substance
ENOXAPARIN SODIUM
Active strength
80 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
Enoxaparin sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENOXAPARIN SODIUM80 mg/.8mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8NZ41MIK1O
Rxcui854228, 854235, 854238, 854241, 854245, 854248, 854252, 854255

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33a7d2c8-f5cf-4d97-8510-92190c5e0f12Product name720240606
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0955-1008-01Enoxaparin sodium0.8 mL in 1 SYRINGEINJECTION0.821
0955-1008-01Enoxaparin sodium1 in 1 CELLO PACKINJECTION121
0955-1008-10Enoxaparin sodium10 in 1 CARTONINJECTION1021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0955-1008-01ML - Milliliter0955-10086d1a4ded-5d18-4c03-9d46-739604ccedd412021-05-05
0955-1008-10ML - Milliliter0955-1008fcce0836-6a22-4540-8066-2f134423847912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
enoxaparin sodiumACTIVE INGREDIENT8NZ41MIK1OENOXAPARIN SODIUM INJECTION [WINTHROP U.S.]8
enoxaparinACTIVE MOIETYE47C0NF7LVENOXAPARIN SODIUM INJECTION [WINTHROP U.S.]8
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHENOXAPARIN SODIUM INJECTION [WINTHROP U.S.]8
waterINACTIVE INGREDIENT059QF0KO0RENOXAPARIN SODIUM INJECTION [WINTHROP U.S.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0955-1008ENOXAPARIN SODIUM INJECTION [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC]17Current NDC, Legacy NDC, 3 package rows20231208_20635579-c92d-4f6c-a332-1096d51002f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854248enoxaparin sodium 100 MG in 1 ML Prefilled SyringePSN20635579-c92d-4f6c-a332-1096d51002f221
854255enoxaparin sodium 100 MG/ML Injectable SolutionPSN20635579-c92d-4f6c-a332-1096d51002f221
854245enoxaparin sodium 120 MG in 0.8 ML Prefilled SyringePSN20635579-c92d-4f6c-a332-1096d51002f221
854252enoxaparin sodium 150 MG in 1 ML Prefilled SyringePSN20635579-c92d-4f6c-a332-1096d51002f221
854228enoxaparin sodium 30 MG in 0.3 ML Prefilled SyringePSN20635579-c92d-4f6c-a332-1096d51002f221
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSN20635579-c92d-4f6c-a332-1096d51002f221
854238enoxaparin sodium 60 MG in 0.6 ML Prefilled SyringePSN20635579-c92d-4f6c-a332-1096d51002f221
854241enoxaparin sodium 80 MG in 0.8 ML Prefilled SyringePSN20635579-c92d-4f6c-a332-1096d51002f221
8542280.3 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD20635579-c92d-4f6c-a332-1096d51002f221
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD20635579-c92d-4f6c-a332-1096d51002f221
8542380.6 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD20635579-c92d-4f6c-a332-1096d51002f221
8542410.8 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD20635579-c92d-4f6c-a332-1096d51002f221
8542450.8 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCD20635579-c92d-4f6c-a332-1096d51002f221
8542481 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD20635579-c92d-4f6c-a332-1096d51002f221
8542521 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCD20635579-c92d-4f6c-a332-1096d51002f221
854255enoxaparin sodium 100 MG/ML Injectable SolutionSCD20635579-c92d-4f6c-a332-1096d51002f221
8542280.3 ML ENX sodium 100 MG/ML Prefilled SyringeSY20635579-c92d-4f6c-a332-1096d51002f221
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSY20635579-c92d-4f6c-a332-1096d51002f221
8542380.6 ML ENX sodium 100 MG/ML Prefilled SyringeSY20635579-c92d-4f6c-a332-1096d51002f221
8542410.8 ML ENX sodium 100 MG/ML Prefilled SyringeSY20635579-c92d-4f6c-a332-1096d51002f221
8542450.8 ML ENX sodium 150 MG/ML Prefilled SyringeSY20635579-c92d-4f6c-a332-1096d51002f221
8542481 ML ENX sodium 100 MG/ML Prefilled SyringeSY20635579-c92d-4f6c-a332-1096d51002f221
8542521 ML ENX sodium 150 MG/ML Prefilled SyringeSY20635579-c92d-4f6c-a332-1096d51002f221
854252enoxaparin 150 MG per 1 ML Prefilled SyringeSY20635579-c92d-4f6c-a332-1096d51002f221
854248enoxaparin sodium 100 MG per 1 ML Prefilled SyringeSY20635579-c92d-4f6c-a332-1096d51002f221
854245enoxaparin sodium 120 MG per 0.8 ML Prefilled SyringeSY20635579-c92d-4f6c-a332-1096d51002f221
854228enoxaparin sodium 30 MG per 0.3 ML Prefilled SyringeSY20635579-c92d-4f6c-a332-1096d51002f221
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSY20635579-c92d-4f6c-a332-1096d51002f221
854238enoxaparin sodium 60 MG per 0.6 ML Prefilled SyringeSY20635579-c92d-4f6c-a332-1096d51002f221
854241enoxaparin sodium 80 MG per 0.8 ML Prefilled SyringeSY20635579-c92d-4f6c-a332-1096d51002f221
854255ENX sodium 100 MG/ML Injectable SolutionSY20635579-c92d-4f6c-a332-1096d51002f221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0955-1008-01009551008010.8 mL in 1 SYRINGE0.8 mlHistorical
0955-1008-100095510081010 CELLO PACK in 1 CARTON (0955-1008-10) / 1 SYRINGE in 1 CELLO PACK (0955-1008-01) / .8 mL in 1 SYRINGE10 cello pack2011-10-030000-00-00NoNoCurrent