FDA.reportPublic FDA data

Enoxaparin Sodium

Product NDC
55154-3540
11-digit product format
551543540
Labeler code
55154
Product ID
55154-3540_5894db55-5339-46b2-9683-4a1d35d4adf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enoxaparin Sodium
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Cardinal Health 107, LLC
Application
ANDA077857
Marketing category
ANDA
Marketing start
2010-07-23
Substance
ENOXAPARIN SODIUM
Active strength
100 mg/mL
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 SODIUM100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8NZ41MIK1O
Rxcui854228, 854235, 854238, 854241, 854248

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
55154-3540-5Enoxaparin Sodium5 in 1 BAGINJECTION57
55154-3540-5Enoxaparin Sodium0.3 mL in 1 SYRINGEINJECTION0.37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-3540ENOXAPARIN SODIUM INJECTION [CARDINAL HEALTH 107, LLC]5Current NDC, Legacy NDC, 2 package rows20250302_5e7568a6-cf8a-4de2-86ba-b94c8ab4c806.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854248enoxaparin sodium 100 MG in 1 ML Prefilled SyringePSN5e7568a6-cf8a-4de2-86ba-b94c8ab4c8067
854228enoxaparin sodium 30 MG in 0.3 ML Prefilled SyringePSN5e7568a6-cf8a-4de2-86ba-b94c8ab4c8067
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSN5e7568a6-cf8a-4de2-86ba-b94c8ab4c8067
854238enoxaparin sodium 60 MG in 0.6 ML Prefilled SyringePSN5e7568a6-cf8a-4de2-86ba-b94c8ab4c8067
854241enoxaparin sodium 80 MG in 0.8 ML Prefilled SyringePSN5e7568a6-cf8a-4de2-86ba-b94c8ab4c8067
8542280.3 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD5e7568a6-cf8a-4de2-86ba-b94c8ab4c8067
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD5e7568a6-cf8a-4de2-86ba-b94c8ab4c8067
8542380.6 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD5e7568a6-cf8a-4de2-86ba-b94c8ab4c8067
8542410.8 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD5e7568a6-cf8a-4de2-86ba-b94c8ab4c8067
8542481 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD5e7568a6-cf8a-4de2-86ba-b94c8ab4c8067
8542280.3 ML ENX sodium 100 MG/ML Prefilled SyringeSY5e7568a6-cf8a-4de2-86ba-b94c8ab4c8067
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSY5e7568a6-cf8a-4de2-86ba-b94c8ab4c8067
8542380.6 ML ENX sodium 100 MG/ML Prefilled SyringeSY5e7568a6-cf8a-4de2-86ba-b94c8ab4c8067
8542410.8 ML ENX sodium 100 MG/ML Prefilled SyringeSY5e7568a6-cf8a-4de2-86ba-b94c8ab4c8067
8542481 ML ENX sodium 100 MG/ML Prefilled SyringeSY5e7568a6-cf8a-4de2-86ba-b94c8ab4c8067
854248enoxaparin sodium 100 MG per 1 ML Prefilled SyringeSY5e7568a6-cf8a-4de2-86ba-b94c8ab4c8067
854228enoxaparin sodium 30 MG per 0.3 ML Prefilled SyringeSY5e7568a6-cf8a-4de2-86ba-b94c8ab4c8067
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSY5e7568a6-cf8a-4de2-86ba-b94c8ab4c8067
854238enoxaparin sodium 60 MG per 0.6 ML Prefilled SyringeSY5e7568a6-cf8a-4de2-86ba-b94c8ab4c8067
854241enoxaparin sodium 80 MG per 0.8 ML Prefilled SyringeSY5e7568a6-cf8a-4de2-86ba-b94c8ab4c8067

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-3540-5551543540055 SYRINGE in 1 BAG (55154-3540-5) / .3 mL in 1 SYRINGE5 syringe2021-02-160000-00-00NoNoCurrent