FDA.reportPublic FDA data

Enoxaparin Sodium

Product NDC
72603-165
11-digit product format
726030165
Labeler code
72603
Product ID
72603-165_1b5d6d46-a8fc-ed74-e063-6294a90af6c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enoxaparin Sodium
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
NorthStar RxLLC
Application
ANDA205660
Marketing category
ANDA
Marketing start
2023-03-15
Substance
ENOXAPARIN SODIUM
Active strength
30 mg/.3mL
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 SODIUM30 mg/.3mL

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-165-01Enoxaparin Sodium0.3 mL in 1 SYRINGEINJECTION, SOLUTION0.33
72603-165-10Enoxaparin Sodium10 in 1 CARTONINJECTION, SOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-165-01ML - Milliliter72603-1654b0772e5-04d7-43c8-ac1a-4fa9ed57101a12023-10-16
72603-165-10ML - Milliliter72603-1652ce27663-6718-451f-9a3c-6930b054887912023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-165ENOXAPARIN SODIUM INJECTION, SOLUTION [NORTHSTAR RXLLC]3Current NDC, 2 package rows20241030_014c6710-f2c4-fd1e-e063-6394a90ae525.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854248enoxaparin sodium 100 MG in 1 ML Prefilled SyringePSN014c6710-f2c4-fd1e-e063-6394a90ae5253
854245enoxaparin sodium 120 MG in 0.8 ML Prefilled SyringePSN014c6710-f2c4-fd1e-e063-6394a90ae5253
854252enoxaparin sodium 150 MG in 1 ML Prefilled SyringePSN014c6710-f2c4-fd1e-e063-6394a90ae5253
854228enoxaparin sodium 30 MG in 0.3 ML Prefilled SyringePSN014c6710-f2c4-fd1e-e063-6394a90ae5253
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSN014c6710-f2c4-fd1e-e063-6394a90ae5253
854238enoxaparin sodium 60 MG in 0.6 ML Prefilled SyringePSN014c6710-f2c4-fd1e-e063-6394a90ae5253
854241enoxaparin sodium 80 MG in 0.8 ML Prefilled SyringePSN014c6710-f2c4-fd1e-e063-6394a90ae5253
8542280.3 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD014c6710-f2c4-fd1e-e063-6394a90ae5253
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD014c6710-f2c4-fd1e-e063-6394a90ae5253
8542380.6 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD014c6710-f2c4-fd1e-e063-6394a90ae5253
8542410.8 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD014c6710-f2c4-fd1e-e063-6394a90ae5253
8542450.8 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCD014c6710-f2c4-fd1e-e063-6394a90ae5253
8542481 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD014c6710-f2c4-fd1e-e063-6394a90ae5253
8542521 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCD014c6710-f2c4-fd1e-e063-6394a90ae5253
8542280.3 ML ENX sodium 100 MG/ML Prefilled SyringeSY014c6710-f2c4-fd1e-e063-6394a90ae5253
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSY014c6710-f2c4-fd1e-e063-6394a90ae5253
8542380.6 ML ENX sodium 100 MG/ML Prefilled SyringeSY014c6710-f2c4-fd1e-e063-6394a90ae5253
8542410.8 ML ENX sodium 100 MG/ML Prefilled SyringeSY014c6710-f2c4-fd1e-e063-6394a90ae5253
8542450.8 ML ENX sodium 150 MG/ML Prefilled SyringeSY014c6710-f2c4-fd1e-e063-6394a90ae5253
8542481 ML ENX sodium 100 MG/ML Prefilled SyringeSY014c6710-f2c4-fd1e-e063-6394a90ae5253
8542521 ML ENX sodium 150 MG/ML Prefilled SyringeSY014c6710-f2c4-fd1e-e063-6394a90ae5253
854252enoxaparin 150 MG per 1 ML Prefilled SyringeSY014c6710-f2c4-fd1e-e063-6394a90ae5253
854248enoxaparin sodium 100 MG per 1 ML Prefilled SyringeSY014c6710-f2c4-fd1e-e063-6394a90ae5253
854245enoxaparin sodium 120 MG per 0.8 ML Prefilled SyringeSY014c6710-f2c4-fd1e-e063-6394a90ae5253
854228enoxaparin sodium 30 MG per 0.3 ML Prefilled SyringeSY014c6710-f2c4-fd1e-e063-6394a90ae5253
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSY014c6710-f2c4-fd1e-e063-6394a90ae5253
854238enoxaparin sodium 60 MG per 0.6 ML Prefilled SyringeSY014c6710-f2c4-fd1e-e063-6394a90ae5253
854241enoxaparin sodium 80 MG per 0.8 ML Prefilled SyringeSY014c6710-f2c4-fd1e-e063-6394a90ae5253

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-165-01726030165010.3 mL in 1 SYRINGE0.3 mlHistorical
72603-165-107260301651010 SYRINGE in 1 CARTON (72603-165-10) / .3 mL in 1 SYRINGE (72603-165-01) 10 syringe2023-07-14NoNoHistorical