FDA.reportPublic FDA data

ENOXAPARIN SODIUM

Product NDC
68083-640
11-digit product format
680830640
Labeler code
68083
Product ID
68083-640_24d882c6-ad8c-488a-a3ab-810f5feb4025
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ENOXAPARIN SODIUM
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Gland Pharma Limited
Application
ANDA078990
Marketing category
ANDA
Marketing start
2023-07-11
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ENOXAPARIN SODIUM
Listing expiration
2027-12-31

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
68083-640-10ENOXAPARIN SODIUM10 in 1 CARTONINJECTION102
68083-640-10ENOXAPARIN SODIUM1 mL in 1 SYRINGEINJECTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-640ENOXAPARIN SODIUM INJECTION [GLAND PHARMA LIMITED]1Current NDC, 2 package rows20230921_65025e0d-eb54-4c4e-bd14-f294ce038902.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854248enoxaparin sodium 100 MG in 1 ML Prefilled SyringePSN65025e0d-eb54-4c4e-bd14-f294ce0389022
854245enoxaparin sodium 120 MG in 0.8 ML Prefilled SyringePSN65025e0d-eb54-4c4e-bd14-f294ce0389022
854252enoxaparin sodium 150 MG in 1 ML Prefilled SyringePSN65025e0d-eb54-4c4e-bd14-f294ce0389022
854228enoxaparin sodium 30 MG in 0.3 ML Prefilled SyringePSN65025e0d-eb54-4c4e-bd14-f294ce0389022
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSN65025e0d-eb54-4c4e-bd14-f294ce0389022
854238enoxaparin sodium 60 MG in 0.6 ML Prefilled SyringePSN65025e0d-eb54-4c4e-bd14-f294ce0389022
854241enoxaparin sodium 80 MG in 0.8 ML Prefilled SyringePSN65025e0d-eb54-4c4e-bd14-f294ce0389022
8542280.3 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD65025e0d-eb54-4c4e-bd14-f294ce0389022
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD65025e0d-eb54-4c4e-bd14-f294ce0389022
8542380.6 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD65025e0d-eb54-4c4e-bd14-f294ce0389022
8542410.8 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD65025e0d-eb54-4c4e-bd14-f294ce0389022
8542450.8 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCD65025e0d-eb54-4c4e-bd14-f294ce0389022
8542481 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD65025e0d-eb54-4c4e-bd14-f294ce0389022
8542521 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCD65025e0d-eb54-4c4e-bd14-f294ce0389022
8542280.3 ML ENX sodium 100 MG/ML Prefilled SyringeSY65025e0d-eb54-4c4e-bd14-f294ce0389022
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSY65025e0d-eb54-4c4e-bd14-f294ce0389022
8542380.6 ML ENX sodium 100 MG/ML Prefilled SyringeSY65025e0d-eb54-4c4e-bd14-f294ce0389022
8542410.8 ML ENX sodium 100 MG/ML Prefilled SyringeSY65025e0d-eb54-4c4e-bd14-f294ce0389022
8542450.8 ML ENX sodium 150 MG/ML Prefilled SyringeSY65025e0d-eb54-4c4e-bd14-f294ce0389022
8542481 ML ENX sodium 100 MG/ML Prefilled SyringeSY65025e0d-eb54-4c4e-bd14-f294ce0389022
8542521 ML ENX sodium 150 MG/ML Prefilled SyringeSY65025e0d-eb54-4c4e-bd14-f294ce0389022
854252enoxaparin 150 MG per 1 ML Prefilled SyringeSY65025e0d-eb54-4c4e-bd14-f294ce0389022
854248enoxaparin sodium 100 MG per 1 ML Prefilled SyringeSY65025e0d-eb54-4c4e-bd14-f294ce0389022
854245enoxaparin sodium 120 MG per 0.8 ML Prefilled SyringeSY65025e0d-eb54-4c4e-bd14-f294ce0389022
854228enoxaparin sodium 30 MG per 0.3 ML Prefilled SyringeSY65025e0d-eb54-4c4e-bd14-f294ce0389022
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSY65025e0d-eb54-4c4e-bd14-f294ce0389022
854238enoxaparin sodium 60 MG per 0.6 ML Prefilled SyringeSY65025e0d-eb54-4c4e-bd14-f294ce0389022
854241enoxaparin sodium 80 MG per 0.8 ML Prefilled SyringeSY65025e0d-eb54-4c4e-bd14-f294ce0389022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68083-640-106808306401010 SYRINGE in 1 CARTON (68083-640-10) / 1 mL in 1 SYRINGE10 syringe2023-07-11NoNoCurrent