Enoxaparin Sodium

Product NDC
16714-046
11-digit product format
167140046
Labeler code
16714
Product ID
16714-046_9f9af4cb-9c7e-471c-8a8a-7b476631d4b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enoxaparin Sodium
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
NorthStar Rx LLC
Application
ANDA206834
Marketing category
ANDA
Marketing start
2019-12-01
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
16714-046-01Enoxaparin Sodium1 mL in 1 SYRINGEINJECTION18
16714-046-10Enoxaparin Sodium10 in 1 CARTONINJECTION108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-046ENOXAPARIN SODIUM INJECTION [NORTHSTAR RX LLC]8Current NDC, Legacy NDC, 2 package rows20241208_32f8d292-0dda-4931-81ea-ba47e23edf61.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854248enoxaparin sodium 100 MG in 1 ML Prefilled SyringePSN32f8d292-0dda-4931-81ea-ba47e23edf618
854245enoxaparin sodium 120 MG in 0.8 ML Prefilled SyringePSN32f8d292-0dda-4931-81ea-ba47e23edf618
854252enoxaparin sodium 150 MG in 1 ML Prefilled SyringePSN32f8d292-0dda-4931-81ea-ba47e23edf618
854228enoxaparin sodium 30 MG in 0.3 ML Prefilled SyringePSN32f8d292-0dda-4931-81ea-ba47e23edf618
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSN32f8d292-0dda-4931-81ea-ba47e23edf618
854238enoxaparin sodium 60 MG in 0.6 ML Prefilled SyringePSN32f8d292-0dda-4931-81ea-ba47e23edf618
854241enoxaparin sodium 80 MG in 0.8 ML Prefilled SyringePSN32f8d292-0dda-4931-81ea-ba47e23edf618
8542280.3 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD32f8d292-0dda-4931-81ea-ba47e23edf618
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD32f8d292-0dda-4931-81ea-ba47e23edf618
8542380.6 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD32f8d292-0dda-4931-81ea-ba47e23edf618
8542410.8 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD32f8d292-0dda-4931-81ea-ba47e23edf618
8542450.8 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCD32f8d292-0dda-4931-81ea-ba47e23edf618
8542481 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD32f8d292-0dda-4931-81ea-ba47e23edf618
8542521 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCD32f8d292-0dda-4931-81ea-ba47e23edf618
8542280.3 ML ENX sodium 100 MG/ML Prefilled SyringeSY32f8d292-0dda-4931-81ea-ba47e23edf618
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSY32f8d292-0dda-4931-81ea-ba47e23edf618
8542380.6 ML ENX sodium 100 MG/ML Prefilled SyringeSY32f8d292-0dda-4931-81ea-ba47e23edf618
8542410.8 ML ENX sodium 100 MG/ML Prefilled SyringeSY32f8d292-0dda-4931-81ea-ba47e23edf618
8542450.8 ML ENX sodium 150 MG/ML Prefilled SyringeSY32f8d292-0dda-4931-81ea-ba47e23edf618
8542481 ML ENX sodium 100 MG/ML Prefilled SyringeSY32f8d292-0dda-4931-81ea-ba47e23edf618
8542521 ML ENX sodium 150 MG/ML Prefilled SyringeSY32f8d292-0dda-4931-81ea-ba47e23edf618
854252enoxaparin 150 MG per 1 ML Prefilled SyringeSY32f8d292-0dda-4931-81ea-ba47e23edf618
854248enoxaparin sodium 100 MG per 1 ML Prefilled SyringeSY32f8d292-0dda-4931-81ea-ba47e23edf618
854245enoxaparin sodium 120 MG per 0.8 ML Prefilled SyringeSY32f8d292-0dda-4931-81ea-ba47e23edf618
854228enoxaparin sodium 30 MG per 0.3 ML Prefilled SyringeSY32f8d292-0dda-4931-81ea-ba47e23edf618
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSY32f8d292-0dda-4931-81ea-ba47e23edf618
854238enoxaparin sodium 60 MG per 0.6 ML Prefilled SyringeSY32f8d292-0dda-4931-81ea-ba47e23edf618
854241enoxaparin sodium 80 MG per 0.8 ML Prefilled SyringeSY32f8d292-0dda-4931-81ea-ba47e23edf618

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-046-01167140046011 mL in 1 SYRINGE1 mlHistorical
16714-046-101671400461010 SYRINGE in 1 CARTON (16714-046-10) / 1 mL in 1 SYRINGE (16714-046-01) 10 syringe2019-12-010000-00-00NoNoCurrent