FDA.reportPublic FDA data

Enoxaparin Sodium

Product NDC
25021-410
11-digit product format
250210410
Labeler code
25021
Product ID
25021-410_0f60383f-d466-4b5b-a501-62dda52eb3b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enoxaparin Sodium
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA078990
Marketing category
ANDA
Marketing start
2023-10-01
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
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 SODIUM100 mg/mL

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
25021-410-70Enoxaparin Sodium10 in 1 CARTONINJECTION101
25021-410-70Enoxaparin Sodium0.3 mL in 1 SYRINGEINJECTION0.31
25021-410-71Enoxaparin Sodium10 in 1 CARTONINJECTION101
25021-410-71Enoxaparin Sodium1 mL in 1 SYRINGEINJECTION11
25021-410-76Enoxaparin Sodium10 in 1 CARTONINJECTION101
25021-410-76Enoxaparin Sodium0.4 mL in 1 SYRINGEINJECTION0.41
25021-410-77Enoxaparin Sodium10 in 1 CARTONINJECTION101
25021-410-77Enoxaparin Sodium0.6 mL in 1 SYRINGEINJECTION0.61
25021-410-78Enoxaparin Sodium10 in 1 CARTONINJECTION101
25021-410-78Enoxaparin Sodium0.8 mL in 1 SYRINGEINJECTION0.81

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-410-70ML - Milliliter25021-4109d3df175-fdc9-4a6e-b643-e192ff1d39cb12024-01-04
25021-410-71ML - Milliliter25021-410e4107b48-03ec-41e2-b6b0-761e00354de112024-01-04
25021-410-76ML - Milliliter25021-410193d91c3-8af8-4933-a9ab-314244761f6b12024-01-04
25021-410-77ML - Milliliter25021-4107b81fd25-8269-452e-be91-9c939a79152412024-01-04
25021-410-78ML - Milliliter25021-410067486aa-3093-4c57-9d92-6ab75768378a12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-410ENOXAPARIN SODIUM INJECTION [SAGENT PHARMACEUTICALS]1Current NDC, 10 package rows20231004_419a3566-4f67-4c8d-86e5-c00c7ec429e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854248enoxaparin sodium 100 MG in 1 ML Prefilled SyringePSN419a3566-4f67-4c8d-86e5-c00c7ec429e11
854245enoxaparin sodium 120 MG in 0.8 ML Prefilled SyringePSN419a3566-4f67-4c8d-86e5-c00c7ec429e11
854252enoxaparin sodium 150 MG in 1 ML Prefilled SyringePSN419a3566-4f67-4c8d-86e5-c00c7ec429e11
854228enoxaparin sodium 30 MG in 0.3 ML Prefilled SyringePSN419a3566-4f67-4c8d-86e5-c00c7ec429e11
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSN419a3566-4f67-4c8d-86e5-c00c7ec429e11
854238enoxaparin sodium 60 MG in 0.6 ML Prefilled SyringePSN419a3566-4f67-4c8d-86e5-c00c7ec429e11
854241enoxaparin sodium 80 MG in 0.8 ML Prefilled SyringePSN419a3566-4f67-4c8d-86e5-c00c7ec429e11
8542280.3 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD419a3566-4f67-4c8d-86e5-c00c7ec429e11
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD419a3566-4f67-4c8d-86e5-c00c7ec429e11
8542380.6 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD419a3566-4f67-4c8d-86e5-c00c7ec429e11
8542410.8 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD419a3566-4f67-4c8d-86e5-c00c7ec429e11
8542450.8 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCD419a3566-4f67-4c8d-86e5-c00c7ec429e11
8542481 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD419a3566-4f67-4c8d-86e5-c00c7ec429e11
8542521 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCD419a3566-4f67-4c8d-86e5-c00c7ec429e11
8542280.3 ML ENX sodium 100 MG/ML Prefilled SyringeSY419a3566-4f67-4c8d-86e5-c00c7ec429e11
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSY419a3566-4f67-4c8d-86e5-c00c7ec429e11
8542380.6 ML ENX sodium 100 MG/ML Prefilled SyringeSY419a3566-4f67-4c8d-86e5-c00c7ec429e11
8542410.8 ML ENX sodium 100 MG/ML Prefilled SyringeSY419a3566-4f67-4c8d-86e5-c00c7ec429e11
8542450.8 ML ENX sodium 150 MG/ML Prefilled SyringeSY419a3566-4f67-4c8d-86e5-c00c7ec429e11
8542481 ML ENX sodium 100 MG/ML Prefilled SyringeSY419a3566-4f67-4c8d-86e5-c00c7ec429e11
8542521 ML ENX sodium 150 MG/ML Prefilled SyringeSY419a3566-4f67-4c8d-86e5-c00c7ec429e11
854252enoxaparin 150 MG per 1 ML Prefilled SyringeSY419a3566-4f67-4c8d-86e5-c00c7ec429e11
854248enoxaparin sodium 100 MG per 1 ML Prefilled SyringeSY419a3566-4f67-4c8d-86e5-c00c7ec429e11
854245enoxaparin sodium 120 MG per 0.8 ML Prefilled SyringeSY419a3566-4f67-4c8d-86e5-c00c7ec429e11
854228enoxaparin sodium 30 MG per 0.3 ML Prefilled SyringeSY419a3566-4f67-4c8d-86e5-c00c7ec429e11
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSY419a3566-4f67-4c8d-86e5-c00c7ec429e11
854238enoxaparin sodium 60 MG per 0.6 ML Prefilled SyringeSY419a3566-4f67-4c8d-86e5-c00c7ec429e11
854241enoxaparin sodium 80 MG per 0.8 ML Prefilled SyringeSY419a3566-4f67-4c8d-86e5-c00c7ec429e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-410-702502104107010 SYRINGE in 1 CARTON (25021-410-70) / .3 mL in 1 SYRINGE10 syringe2023-10-01NoNoHistorical
25021-410-712502104107110 SYRINGE in 1 CARTON (25021-410-71) / 1 mL in 1 SYRINGE10 syringe2023-10-01NoNoHistorical
25021-410-762502104107610 SYRINGE in 1 CARTON (25021-410-76) / .4 mL in 1 SYRINGE10 syringe2023-10-01NoNoHistorical
25021-410-772502104107710 SYRINGE in 1 CARTON (25021-410-77) / .6 mL in 1 SYRINGE10 syringe2023-10-01NoNoHistorical
25021-410-782502104107810 SYRINGE in 1 CARTON (25021-410-78) / .8 mL in 1 SYRINGE10 syringe2023-10-01NoNoHistorical