FDA.reportPublic FDA data

Enoxaparin Sodium

Product NDC
63323-586
11-digit product format
633230586
Labeler code
63323
Product ID
63323-586_2b6f0c59-240a-48ec-9cef-e55cc4b52274
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enoxaparin Sodium
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA078990
Marketing category
ANDA
Marketing start
2019-04-23
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
63323-586-21Enoxaparin Sodium1 in 1 BLISTER PACKINJECTION19
63323-586-21Enoxaparin Sodium1 mL in 1 SYRINGEINJECTION19
63323-586-96Enoxaparin Sodium10 in 1 CARTONINJECTION109
63323-586-63Enoxaparin Sodium1 mL in 1 SYRINGEINJECTION13
63323-586-63Enoxaparin Sodium1 in 1 BLISTER PACKINJECTION13
63323-586-65Enoxaparin Sodium10 in 1 CARTONINJECTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-586-21ML - Milliliter63323-586ee0cab85-a2af-441b-b7c1-a195a2ab27ae12019-11-12
63323-586-63ML - Milliliter63323-5864f2723c3-fb03-43ac-a63a-adf57f50c96312023-02-06
63323-586-65ML - Milliliter63323-586ef850f10-39d5-494d-ad05-1a77ddc49ead12023-02-06
63323-586-96ML - Milliliter63323-5863cd63b81-114f-425e-9ef4-e1a03db8318512019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-586ENOXAPARIN SODIUM INJECTION [FRESENIUS KABI USA, LLC]8Current NDC, Legacy NDC, 3 package rows20240731_a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e.zip
63323-586ENOXAPARIN SODIUM INJECTION [FRESENIUS KABI USA, LLC]2Current NDC, Legacy NDC, 3 package rows20230623_c3be543e-8aff-4311-bf77-e7a5a814ca6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854248enoxaparin sodium 100 MG in 1 ML Prefilled SyringePSNa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
854245enoxaparin sodium 120 MG in 0.8 ML Prefilled SyringePSNa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
854252enoxaparin sodium 150 MG in 1 ML Prefilled SyringePSNa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
854228enoxaparin sodium 30 MG in 0.3 ML Prefilled SyringePSNa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSNa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
854238enoxaparin sodium 60 MG in 0.6 ML Prefilled SyringePSNa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
854241enoxaparin sodium 80 MG in 0.8 ML Prefilled SyringePSNa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
8542280.3 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
8542380.6 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
8542410.8 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
8542450.8 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCDa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
8542481 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
8542521 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCDa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
8542280.3 ML ENX sodium 100 MG/ML Prefilled SyringeSYa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSYa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
8542380.6 ML ENX sodium 100 MG/ML Prefilled SyringeSYa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
8542410.8 ML ENX sodium 100 MG/ML Prefilled SyringeSYa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
8542450.8 ML ENX sodium 150 MG/ML Prefilled SyringeSYa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
8542481 ML ENX sodium 100 MG/ML Prefilled SyringeSYa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
8542521 ML ENX sodium 150 MG/ML Prefilled SyringeSYa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
854252enoxaparin 150 MG per 1 ML Prefilled SyringeSYa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
854248enoxaparin sodium 100 MG per 1 ML Prefilled SyringeSYa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
854245enoxaparin sodium 120 MG per 0.8 ML Prefilled SyringeSYa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
854228enoxaparin sodium 30 MG per 0.3 ML Prefilled SyringeSYa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSYa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
854238enoxaparin sodium 60 MG per 0.6 ML Prefilled SyringeSYa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
854241enoxaparin sodium 80 MG per 0.8 ML Prefilled SyringeSYa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e9
854248enoxaparin sodium 100 MG in 1 ML Prefilled SyringePSNc3be543e-8aff-4311-bf77-e7a5a814ca6f3
854228enoxaparin sodium 30 MG in 0.3 ML Prefilled SyringePSNc3be543e-8aff-4311-bf77-e7a5a814ca6f3
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSNc3be543e-8aff-4311-bf77-e7a5a814ca6f3
854238enoxaparin sodium 60 MG in 0.6 ML Prefilled SyringePSNc3be543e-8aff-4311-bf77-e7a5a814ca6f3
854241enoxaparin sodium 80 MG in 0.8 ML Prefilled SyringePSNc3be543e-8aff-4311-bf77-e7a5a814ca6f3
8542280.3 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDc3be543e-8aff-4311-bf77-e7a5a814ca6f3
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDc3be543e-8aff-4311-bf77-e7a5a814ca6f3
8542380.6 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDc3be543e-8aff-4311-bf77-e7a5a814ca6f3
8542410.8 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDc3be543e-8aff-4311-bf77-e7a5a814ca6f3
8542481 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDc3be543e-8aff-4311-bf77-e7a5a814ca6f3
8542280.3 ML ENX sodium 100 MG/ML Prefilled SyringeSYc3be543e-8aff-4311-bf77-e7a5a814ca6f3
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSYc3be543e-8aff-4311-bf77-e7a5a814ca6f3
8542380.6 ML ENX sodium 100 MG/ML Prefilled SyringeSYc3be543e-8aff-4311-bf77-e7a5a814ca6f3
8542410.8 ML ENX sodium 100 MG/ML Prefilled SyringeSYc3be543e-8aff-4311-bf77-e7a5a814ca6f3
8542481 ML ENX sodium 100 MG/ML Prefilled SyringeSYc3be543e-8aff-4311-bf77-e7a5a814ca6f3
854248enoxaparin sodium 100 MG per 1 ML Prefilled SyringeSYc3be543e-8aff-4311-bf77-e7a5a814ca6f3
854228enoxaparin sodium 30 MG per 0.3 ML Prefilled SyringeSYc3be543e-8aff-4311-bf77-e7a5a814ca6f3
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSYc3be543e-8aff-4311-bf77-e7a5a814ca6f3
854238enoxaparin sodium 60 MG per 0.6 ML Prefilled SyringeSYc3be543e-8aff-4311-bf77-e7a5a814ca6f3
854241enoxaparin sodium 80 MG per 0.8 ML Prefilled SyringeSYc3be543e-8aff-4311-bf77-e7a5a814ca6f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-586-21633230586211 in 1 BLISTER PACKHistorical
63323-586-63633230586631 mL in 1 SYRINGE1 mlHistorical
63323-586-656332305866510 BLISTER PACK in 1 CARTON (63323-586-65) / 1 SYRINGE in 1 BLISTER PACK (63323-586-63) / 1 mL in 1 SYRINGE10 blister pack2019-04-230000-00-00NoNoCurrent
63323-586-966332305869610 BLISTER PACK in 1 CARTON (63323-586-96) / 1 SYRINGE in 1 BLISTER PACK (63323-586-21) / 1 mL in 1 SYRINGE10 blister pack2019-04-230000-00-00NoNoCurrent