FDA.reportPublic FDA data

Enoxaparin Sodium

Product NDC
0781-3298
11-digit product format
007813298
Labeler code
0781
Product ID
0781-3298_82c50153-58b8-4c35-8fc2-1d9b3d3ac7de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enoxaparin Sodium
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Sandoz Inc
Application
ANDA077857
Marketing category
ANDA
Marketing start
2010-07-23
Substance
ENOXAPARIN SODIUM
Active strength
150 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 SODIUM150 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
0781-3298-04Enoxaparin Sodium0.8 mL in 1 SYRINGEINJECTION0.87
0781-3298-68Enoxaparin Sodium10 in 1 CARTONINJECTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3298-04ML - Milliliter0781-3298d72bf00c-bdba-4326-924c-9fed5e4217a412021-03-02
0781-3298-68ML - Milliliter0781-32982f7cf404-8fb4-4a2c-9ec9-ed04f4b5a93712021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3298ENOXAPARIN SODIUM INJECTION [SANDOZ INC]7Current NDC, Legacy NDC, 2 package rows20240912_38f60bd8-b518-4098-a808-b8f5a3ae6a3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854248enoxaparin sodium 100 MG in 1 ML Prefilled SyringePSN38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
854245enoxaparin sodium 120 MG in 0.8 ML Prefilled SyringePSN38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
854252enoxaparin sodium 150 MG in 1 ML Prefilled SyringePSN38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
854228enoxaparin sodium 30 MG in 0.3 ML Prefilled SyringePSN38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSN38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
854238enoxaparin sodium 60 MG in 0.6 ML Prefilled SyringePSN38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
854241enoxaparin sodium 80 MG in 0.8 ML Prefilled SyringePSN38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
8542280.3 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
8542380.6 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
8542410.8 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
8542450.8 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCD38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
8542481 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
8542521 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCD38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
8542280.3 ML ENX sodium 100 MG/ML Prefilled SyringeSY38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSY38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
8542380.6 ML ENX sodium 100 MG/ML Prefilled SyringeSY38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
8542410.8 ML ENX sodium 100 MG/ML Prefilled SyringeSY38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
8542450.8 ML ENX sodium 150 MG/ML Prefilled SyringeSY38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
8542481 ML ENX sodium 100 MG/ML Prefilled SyringeSY38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
8542521 ML ENX sodium 150 MG/ML Prefilled SyringeSY38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
854252enoxaparin 150 MG per 1 ML Prefilled SyringeSY38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
854248enoxaparin sodium 100 MG per 1 ML Prefilled SyringeSY38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
854245enoxaparin sodium 120 MG per 0.8 ML Prefilled SyringeSY38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
854228enoxaparin sodium 30 MG per 0.3 ML Prefilled SyringeSY38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSY38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
854238enoxaparin sodium 60 MG per 0.6 ML Prefilled SyringeSY38f60bd8-b518-4098-a808-b8f5a3ae6a3a7
854241enoxaparin sodium 80 MG per 0.8 ML Prefilled SyringeSY38f60bd8-b518-4098-a808-b8f5a3ae6a3a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-3298-04007813298040.8 mL in 1 SYRINGE0.8 mlHistorical
0781-3298-680078132986810 SYRINGE in 1 CARTON (0781-3298-68) / .8 mL in 1 SYRINGE (0781-3298-04) 10 syringe2021-02-160000-00-00NoNoCurrent