FDA.reportPublic FDA data

enoxaparin sodium

Product NDC
28955-103
11-digit product format
289550103
Labeler code
28955
Product ID
28955-103_486592e2-4eef-525e-e063-6394a90a3048
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
enoxaparin sodium
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Hebei Changshan Biochemical Pharmaceutical Co., Ltd.
Application
ANDA218775
Marketing category
ANDA
Marketing start
2026-05-01
Substance
ENOXAPARIN SODIUM
Active strength
60 mg/.6mL
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 SODIUM60 mg/.6mL

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
28955-103-10enoxaparin sodium0.6 mL in 1 SYRINGEINJECTION0.62
28955-103-10enoxaparin sodium10 in 1 CARTONINJECTION102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854248enoxaparin sodium 100 MG in 1 ML Prefilled SyringePSN7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854245enoxaparin sodium 120 MG in 0.8 ML Prefilled SyringePSN7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854252enoxaparin sodium 150 MG in 1 ML Prefilled SyringePSN7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854228enoxaparin sodium 30 MG in 0.3 ML Prefilled SyringePSN7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSN7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854238enoxaparin sodium 60 MG in 0.6 ML Prefilled SyringePSN7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854241enoxaparin sodium 80 MG in 0.8 ML Prefilled SyringePSN7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542280.3 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542380.6 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542410.8 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542450.8 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCD7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542481 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542521 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCD7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542280.3 ML ENX sodium 100 MG/ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542380.6 ML ENX sodium 100 MG/ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542410.8 ML ENX sodium 100 MG/ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542450.8 ML ENX sodium 150 MG/ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542481 ML ENX sodium 100 MG/ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542521 ML ENX sodium 150 MG/ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854252enoxaparin 150 MG per 1 ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854248enoxaparin sodium 100 MG per 1 ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854245enoxaparin sodium 120 MG per 0.8 ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854228enoxaparin sodium 30 MG per 0.3 ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854238enoxaparin sodium 60 MG per 0.6 ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854241enoxaparin sodium 80 MG per 0.8 ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
28955-103-102895501031010 SYRINGE in 1 CARTON (28955-103-10) / .6 mL in 1 SYRINGE10 syringe2026-05-01NoNoCurrent