FDA.reportPublic FDA data

enoxaparin sodium

Product NDC
71839-110
11-digit product format
718390110
Labeler code
71839
Product ID
71839-110_5db5abf2-d207-4e03-a5cc-8e31f2fa20c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
enoxaparin sodium
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
BE Pharmaceuticals Inc.
Application
ANDA214646
Marketing category
ANDA
Marketing start
2023-06-16
Substance
ENOXAPARIN SODIUM
Active strength
40 mg/.4mL
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 SODIUM40 mg/.4mL

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
71839-110-10enoxaparin sodium0.4 mL in 1 SYRINGEINJECTION0.42
71839-110-10enoxaparin sodium10 in 1 CARTONINJECTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71839-110ENOXAPARIN SODIUM INJECTION [BE PHARMACEUTICALS INC.]2Current NDC, 2 package rows20230831_b7197534-1daa-42de-8b83-a727da1195bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854248enoxaparin sodium 100 MG in 1 ML Prefilled SyringePSNb7197534-1daa-42de-8b83-a727da1195bf2
854245enoxaparin sodium 120 MG in 0.8 ML Prefilled SyringePSNb7197534-1daa-42de-8b83-a727da1195bf2
854252enoxaparin sodium 150 MG in 1 ML Prefilled SyringePSNb7197534-1daa-42de-8b83-a727da1195bf2
854228enoxaparin sodium 30 MG in 0.3 ML Prefilled SyringePSNb7197534-1daa-42de-8b83-a727da1195bf2
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSNb7197534-1daa-42de-8b83-a727da1195bf2
854238enoxaparin sodium 60 MG in 0.6 ML Prefilled SyringePSNb7197534-1daa-42de-8b83-a727da1195bf2
854241enoxaparin sodium 80 MG in 0.8 ML Prefilled SyringePSNb7197534-1daa-42de-8b83-a727da1195bf2
8542280.3 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDb7197534-1daa-42de-8b83-a727da1195bf2
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDb7197534-1daa-42de-8b83-a727da1195bf2
8542380.6 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDb7197534-1daa-42de-8b83-a727da1195bf2
8542410.8 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDb7197534-1daa-42de-8b83-a727da1195bf2
8542450.8 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCDb7197534-1daa-42de-8b83-a727da1195bf2
8542481 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDb7197534-1daa-42de-8b83-a727da1195bf2
8542521 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCDb7197534-1daa-42de-8b83-a727da1195bf2
8542280.3 ML ENX sodium 100 MG/ML Prefilled SyringeSYb7197534-1daa-42de-8b83-a727da1195bf2
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSYb7197534-1daa-42de-8b83-a727da1195bf2
8542380.6 ML ENX sodium 100 MG/ML Prefilled SyringeSYb7197534-1daa-42de-8b83-a727da1195bf2
8542410.8 ML ENX sodium 100 MG/ML Prefilled SyringeSYb7197534-1daa-42de-8b83-a727da1195bf2
8542450.8 ML ENX sodium 150 MG/ML Prefilled SyringeSYb7197534-1daa-42de-8b83-a727da1195bf2
8542481 ML ENX sodium 100 MG/ML Prefilled SyringeSYb7197534-1daa-42de-8b83-a727da1195bf2
8542521 ML ENX sodium 150 MG/ML Prefilled SyringeSYb7197534-1daa-42de-8b83-a727da1195bf2
854252enoxaparin 150 MG per 1 ML Prefilled SyringeSYb7197534-1daa-42de-8b83-a727da1195bf2
854248enoxaparin sodium 100 MG per 1 ML Prefilled SyringeSYb7197534-1daa-42de-8b83-a727da1195bf2
854245enoxaparin sodium 120 MG per 0.8 ML Prefilled SyringeSYb7197534-1daa-42de-8b83-a727da1195bf2
854228enoxaparin sodium 30 MG per 0.3 ML Prefilled SyringeSYb7197534-1daa-42de-8b83-a727da1195bf2
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSYb7197534-1daa-42de-8b83-a727da1195bf2
854238enoxaparin sodium 60 MG per 0.6 ML Prefilled SyringeSYb7197534-1daa-42de-8b83-a727da1195bf2
854241enoxaparin sodium 80 MG per 0.8 ML Prefilled SyringeSYb7197534-1daa-42de-8b83-a727da1195bf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71839-110-107183901101010 SYRINGE in 1 CARTON (71839-110-10) / .4 mL in 1 SYRINGE10 syringe2023-06-16NoNoCurrent