FDA.reportPublic FDA data

Enoxaparin Sodium

Product NDC
63323-539
11-digit product format
633230539
Labeler code
63323
Product ID
63323-539_53e20cb1-9e79-4c45-a5a7-62c3904df818
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
enoxaparin sodium
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA020164
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-06-18
Substance
ENOXAPARIN SODIUM
Active strength
300 mg/3mL
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 SODIUM300 mg/3mL

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-539-03Enoxaparin Sodium1 in 1 CARTONINJECTION19
63323-539-03Enoxaparin Sodium3 mL in 1 VIAL, MULTI-DOSEINJECTION39
63323-539-13Enoxaparin Sodium3 mL in 1 VIAL, MULTI-DOSEINJECTION37
63323-539-13Enoxaparin Sodium1 in 1 CARTONINJECTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-539-03ML - Milliliter63323-5398e0d501c-0e2e-4ea1-8110-3b3ab645032312020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-539ENOXAPARIN SODIUM INJECTION [FRESENIUS KABI USA, LLC]7Current NDC, Legacy NDC, 2 package rows20230105_21b095d1-5ade-43e9-9114-30fbfb2331c9.zip
63323-539ENOXAPARIN SODIUM INJECTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 2 package rows20220125_066f27ec-352c-4051-ba29-248e292690db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854248enoxaparin sodium 100 MG in 1 ML Prefilled SyringePSN21b095d1-5ade-43e9-9114-30fbfb2331c99
854255enoxaparin sodium 100 MG/ML Injectable SolutionPSN21b095d1-5ade-43e9-9114-30fbfb2331c99
854245enoxaparin sodium 120 MG in 0.8 ML Prefilled SyringePSN21b095d1-5ade-43e9-9114-30fbfb2331c99
854252enoxaparin sodium 150 MG in 1 ML Prefilled SyringePSN21b095d1-5ade-43e9-9114-30fbfb2331c99
854228enoxaparin sodium 30 MG in 0.3 ML Prefilled SyringePSN21b095d1-5ade-43e9-9114-30fbfb2331c99
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSN21b095d1-5ade-43e9-9114-30fbfb2331c99
854238enoxaparin sodium 60 MG in 0.6 ML Prefilled SyringePSN21b095d1-5ade-43e9-9114-30fbfb2331c99
854241enoxaparin sodium 80 MG in 0.8 ML Prefilled SyringePSN21b095d1-5ade-43e9-9114-30fbfb2331c99
8542280.3 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD21b095d1-5ade-43e9-9114-30fbfb2331c99
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD21b095d1-5ade-43e9-9114-30fbfb2331c99
8542380.6 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD21b095d1-5ade-43e9-9114-30fbfb2331c99
8542410.8 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD21b095d1-5ade-43e9-9114-30fbfb2331c99
8542450.8 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCD21b095d1-5ade-43e9-9114-30fbfb2331c99
8542481 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD21b095d1-5ade-43e9-9114-30fbfb2331c99
8542521 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCD21b095d1-5ade-43e9-9114-30fbfb2331c99
854255enoxaparin sodium 100 MG/ML Injectable SolutionSCD21b095d1-5ade-43e9-9114-30fbfb2331c99
8542280.3 ML ENX sodium 100 MG/ML Prefilled SyringeSY21b095d1-5ade-43e9-9114-30fbfb2331c99
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSY21b095d1-5ade-43e9-9114-30fbfb2331c99
8542380.6 ML ENX sodium 100 MG/ML Prefilled SyringeSY21b095d1-5ade-43e9-9114-30fbfb2331c99
8542410.8 ML ENX sodium 100 MG/ML Prefilled SyringeSY21b095d1-5ade-43e9-9114-30fbfb2331c99
8542450.8 ML ENX sodium 150 MG/ML Prefilled SyringeSY21b095d1-5ade-43e9-9114-30fbfb2331c99
8542481 ML ENX sodium 100 MG/ML Prefilled SyringeSY21b095d1-5ade-43e9-9114-30fbfb2331c99
8542521 ML ENX sodium 150 MG/ML Prefilled SyringeSY21b095d1-5ade-43e9-9114-30fbfb2331c99
854252enoxaparin 150 MG per 1 ML Prefilled SyringeSY21b095d1-5ade-43e9-9114-30fbfb2331c99
854248enoxaparin sodium 100 MG per 1 ML Prefilled SyringeSY21b095d1-5ade-43e9-9114-30fbfb2331c99
854245enoxaparin sodium 120 MG per 0.8 ML Prefilled SyringeSY21b095d1-5ade-43e9-9114-30fbfb2331c99
854228enoxaparin sodium 30 MG per 0.3 ML Prefilled SyringeSY21b095d1-5ade-43e9-9114-30fbfb2331c99
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSY21b095d1-5ade-43e9-9114-30fbfb2331c99
854238enoxaparin sodium 60 MG per 0.6 ML Prefilled SyringeSY21b095d1-5ade-43e9-9114-30fbfb2331c99
854241enoxaparin sodium 80 MG per 0.8 ML Prefilled SyringeSY21b095d1-5ade-43e9-9114-30fbfb2331c99
854255ENX sodium 100 MG/ML Injectable SolutionSY21b095d1-5ade-43e9-9114-30fbfb2331c99
854248enoxaparin sodium 100 MG in 1 ML Prefilled SyringePSN066f27ec-352c-4051-ba29-248e292690db7
854255enoxaparin sodium 100 MG/ML Injectable SolutionPSN066f27ec-352c-4051-ba29-248e292690db7
854245enoxaparin sodium 120 MG in 0.8 ML Prefilled SyringePSN066f27ec-352c-4051-ba29-248e292690db7
854252enoxaparin sodium 150 MG in 1 ML Prefilled SyringePSN066f27ec-352c-4051-ba29-248e292690db7
854228enoxaparin sodium 30 MG in 0.3 ML Prefilled SyringePSN066f27ec-352c-4051-ba29-248e292690db7
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSN066f27ec-352c-4051-ba29-248e292690db7
854238enoxaparin sodium 60 MG in 0.6 ML Prefilled SyringePSN066f27ec-352c-4051-ba29-248e292690db7
854241enoxaparin sodium 80 MG in 0.8 ML Prefilled SyringePSN066f27ec-352c-4051-ba29-248e292690db7
8542280.3 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD066f27ec-352c-4051-ba29-248e292690db7
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD066f27ec-352c-4051-ba29-248e292690db7
8542380.6 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD066f27ec-352c-4051-ba29-248e292690db7
8542410.8 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD066f27ec-352c-4051-ba29-248e292690db7
8542450.8 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCD066f27ec-352c-4051-ba29-248e292690db7
8542481 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD066f27ec-352c-4051-ba29-248e292690db7
8542521 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCD066f27ec-352c-4051-ba29-248e292690db7
854255enoxaparin sodium 100 MG/ML Injectable SolutionSCD066f27ec-352c-4051-ba29-248e292690db7
8542280.3 ML ENX sodium 100 MG/ML Prefilled SyringeSY066f27ec-352c-4051-ba29-248e292690db7
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSY066f27ec-352c-4051-ba29-248e292690db7
8542380.6 ML ENX sodium 100 MG/ML Prefilled SyringeSY066f27ec-352c-4051-ba29-248e292690db7
8542410.8 ML ENX sodium 100 MG/ML Prefilled SyringeSY066f27ec-352c-4051-ba29-248e292690db7
8542450.8 ML ENX sodium 150 MG/ML Prefilled SyringeSY066f27ec-352c-4051-ba29-248e292690db7
8542481 ML ENX sodium 100 MG/ML Prefilled SyringeSY066f27ec-352c-4051-ba29-248e292690db7
8542521 ML ENX sodium 150 MG/ML Prefilled SyringeSY066f27ec-352c-4051-ba29-248e292690db7
854252enoxaparin 150 MG per 1 ML Prefilled SyringeSY066f27ec-352c-4051-ba29-248e292690db7
854248enoxaparin sodium 100 MG per 1 ML Prefilled SyringeSY066f27ec-352c-4051-ba29-248e292690db7
854245enoxaparin sodium 120 MG per 0.8 ML Prefilled SyringeSY066f27ec-352c-4051-ba29-248e292690db7
854228enoxaparin sodium 30 MG per 0.3 ML Prefilled SyringeSY066f27ec-352c-4051-ba29-248e292690db7
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSY066f27ec-352c-4051-ba29-248e292690db7
854238enoxaparin sodium 60 MG per 0.6 ML Prefilled SyringeSY066f27ec-352c-4051-ba29-248e292690db7
854241enoxaparin sodium 80 MG per 0.8 ML Prefilled SyringeSY066f27ec-352c-4051-ba29-248e292690db7
854255ENX sodium 100 MG/ML Injectable SolutionSY066f27ec-352c-4051-ba29-248e292690db7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63323-539-03633230539031 VIAL, MULTI-DOSE in 1 CARTON (63323-539-03) / 3 mL in 1 VIAL, MULTI-DOSE2019-06-180000-00-00NoNoCurrent
63323-539-13633230539131 VIAL, MULTI-DOSE in 1 CARTON (63323-539-13) / 3 mL in 1 VIAL, MULTI-DOSE2019-06-180000-00-00NoNoCurrent