Enoxaparin Sodium

Product NDC
55154-9586
11-digit product format
551549586
Labeler code
55154
Product ID
55154-9586_bc15f03c-6537-4314-96e2-af7d56d9633d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enoxaparin Sodium
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Cardinal Health 107, LLC
Application
ANDA078990
Marketing category
ANDA
Marketing start
2024-07-16
Substance
ENOXAPARIN SODIUM
Active strength
40 mg/.4mL
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 SODIUM40 mg/.4mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8NZ41MIK1O
Rxcui854235

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
55154-9586-5Enoxaparin Sodium5 in 1 BAGINJECTION55
55154-9586-5Enoxaparin Sodium0.4 mL in 1 SYRINGEINJECTION0.45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-9586ENOXAPARIN SODIUM INJECTION [CARDINAL HEALTH 107, LLC]1Current NDC, 2 package rows20240718_45a66675-b159-42b8-9f18-ff80f28e1503.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSN45a66675-b159-42b8-9f18-ff80f28e15035
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD45a66675-b159-42b8-9f18-ff80f28e15035
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSY45a66675-b159-42b8-9f18-ff80f28e15035
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSY45a66675-b159-42b8-9f18-ff80f28e15035

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-9586-5551549586055 SYRINGE in 1 BAG (55154-9586-5) / .4 mL in 1 SYRINGE5 syringe2024-07-16NoNoCurrent