FDA.reportPublic FDA data

Enoxaparin Sodium

Product NDC
11797-758
11-digit product format
117970758
Labeler code
11797
Product ID
11797-758_3102514e-1702-4b7d-9d26-60e98488ffc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enoxaparin Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Italfarmaco SpA
Application
ANDA076726
Marketing category
ANDA
Marketing start
2021-04-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Enoxaparin Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENOXAPARIN SODIUM40 mg/.4mL

Harmonized Identifiers#

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

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
11797-758-02Enoxaparin Sodium0.4 mL in 1 SYRINGEINJECTION, SOLUTION0.42
11797-758-06Enoxaparin Sodium10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11797-758ENOXAPARIN SODIUM INJECTION, SOLUTION [ITALFARMACO SPA]2Current NDC, Legacy NDC, 2 package rows20221122_b4d9e4d4-4fdb-48d6-a169-7bc5eebc51e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854248enoxaparin sodium 100 MG in 1 ML Prefilled SyringePSNb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
854245enoxaparin sodium 120 MG in 0.8 ML Prefilled SyringePSNb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
854252enoxaparin sodium 150 MG in 1 ML Prefilled SyringePSNb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
854228enoxaparin sodium 30 MG in 0.3 ML Prefilled SyringePSNb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSNb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
854238enoxaparin sodium 60 MG in 0.6 ML Prefilled SyringePSNb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
854241enoxaparin sodium 80 MG in 0.8 ML Prefilled SyringePSNb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
8542280.3 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
8542380.6 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
8542410.8 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
8542450.8 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCDb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
8542481 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
8542521 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCDb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
8542280.3 ML ENX sodium 100 MG/ML Prefilled SyringeSYb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSYb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
8542380.6 ML ENX sodium 100 MG/ML Prefilled SyringeSYb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
8542410.8 ML ENX sodium 100 MG/ML Prefilled SyringeSYb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
8542450.8 ML ENX sodium 150 MG/ML Prefilled SyringeSYb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
8542481 ML ENX sodium 100 MG/ML Prefilled SyringeSYb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
8542521 ML ENX sodium 150 MG/ML Prefilled SyringeSYb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
854252enoxaparin 150 MG per 1 ML Prefilled SyringeSYb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
854248enoxaparin sodium 100 MG per 1 ML Prefilled SyringeSYb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
854245enoxaparin sodium 120 MG per 0.8 ML Prefilled SyringeSYb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
854228enoxaparin sodium 30 MG per 0.3 ML Prefilled SyringeSYb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSYb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
854238enoxaparin sodium 60 MG per 0.6 ML Prefilled SyringeSYb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92
854241enoxaparin sodium 80 MG per 0.8 ML Prefilled SyringeSYb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11797-758-02117970758020.4 mL in 1 SYRINGE0.4 mlHistorical
11797-758-061179707580610 SYRINGE in 1 CARTON (11797-758-06) / .4 mL in 1 SYRINGE (11797-758-02) 10 syringe2021-04-010000-00-00NoNoCurrent