FDA.reportPublic FDA data

Enoxaparin Sodium

Product NDC
63323-584
11-digit product format
633230584
Labeler code
63323
Product ID
63323-584_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
80 mg/.8mL
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 SODIUM80 mg/.8mL

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
63323-584-21Enoxaparin Sodium0.8 mL in 1 SYRINGEINJECTION0.89
63323-584-21Enoxaparin Sodium1 in 1 BLISTER PACKINJECTION19
63323-584-99Enoxaparin Sodium10 in 1 CARTONINJECTION109
63323-584-63Enoxaparin Sodium0.8 mL in 1 SYRINGEINJECTION0.83
63323-584-63Enoxaparin Sodium1 in 1 BLISTER PACKINJECTION13
63323-584-65Enoxaparin Sodium10 in 1 CARTONINJECTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-584-21ML - Milliliter63323-5843ab9269d-d4a9-4831-a755-9480ae6073fc12019-11-12
63323-584-63ML - Milliliter63323-584534150ea-61e3-473d-8ce4-7c736a8b682e12022-04-06
63323-584-65ML - Milliliter63323-58433bd07f0-17da-4092-9edc-c90497c9747512022-04-06
63323-584-99ML - Milliliter63323-5841c1cbe3f-6e88-4871-bf85-2b756716fbaf12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-584ENOXAPARIN SODIUM INJECTION [FRESENIUS KABI USA, LLC]8Current NDC, Legacy NDC, 3 package rows20240731_a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e.zip
63323-584ENOXAPARIN 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
63323-584-21633230584210.8 mL in 1 SYRINGE0.8 mlHistorical
63323-584-63633230584630.8 mL in 1 SYRINGE0.8 mlHistorical
63323-584-656332305846510 BLISTER PACK in 1 CARTON (63323-584-65) / 1 SYRINGE in 1 BLISTER PACK (63323-584-63) / .8 mL in 1 SYRINGE10 blister pack2019-04-230000-00-00NoNoCurrent
63323-584-996332305849910 BLISTER PACK in 1 CARTON (63323-584-99) / 1 SYRINGE in 1 BLISTER PACK (63323-584-21) / .8 mL in 1 SYRINGE10 blister pack2019-04-230000-00-00NoNoCurrent