FDA.reportPublic FDA data

Enoxaparin Sodium

Product NDC
0548-5608
11-digit product format
005485608
Labeler code
0548
Product ID
0548-5608_2910408b-d506-4a3a-a2c8-64fc46ba0da0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
enoxaparin sodium
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Amphastar Pharmaceuticals, Inc.
Application
ANDA208600
Marketing category
ANDA
Marketing start
2019-11-11
Substance
ENOXAPARIN SODIUM
Active strength
300 mg/3mL
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 SODIUM300 mg/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8NZ41MIK1O
Rxcui854228, 854235, 854238, 854241, 854245, 854248, 854252, 854255

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
0548-5608-00Enoxaparin Sodium1 in 1 CARTONINJECTION118
0548-5608-00Enoxaparin Sodium3 mL in 1 VIALINJECTION318

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0548-5608-00ML - Milliliter0548-560827924b29-827b-4f7e-9211-5b5b629f91b712019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Enoxaparin sodiumACTIVE INGREDIENT8NZ41MIK1OENOXAPARIN SODIUM INJECTION [AMPHASTAR PHARMACEUTICALS, INC.]6
enoxaparinACTIVE MOIETYE47C0NF7LVENOXAPARIN SODIUM INJECTION [AMPHASTAR PHARMACEUTICALS, INC.]6
waterINACTIVE INGREDIENT059QF0KO0RENOXAPARIN SODIUM INJECTION [AMPHASTAR PHARMACEUTICALS, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0548-5608ENOXAPARIN SODIUM INJECTION ENOXAPARIN SODIUM INJECTION [AMPHASTAR PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 2 package rows20241222_3e6bf2b3-9339-4104-bda3-ad86a1949703.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854248enoxaparin sodium 100 MG in 1 ML Prefilled SyringePSN3e6bf2b3-9339-4104-bda3-ad86a194970318
854255enoxaparin sodium 100 MG/ML Injectable SolutionPSN3e6bf2b3-9339-4104-bda3-ad86a194970318
854245enoxaparin sodium 120 MG in 0.8 ML Prefilled SyringePSN3e6bf2b3-9339-4104-bda3-ad86a194970318
854252enoxaparin sodium 150 MG in 1 ML Prefilled SyringePSN3e6bf2b3-9339-4104-bda3-ad86a194970318
854228enoxaparin sodium 30 MG in 0.3 ML Prefilled SyringePSN3e6bf2b3-9339-4104-bda3-ad86a194970318
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSN3e6bf2b3-9339-4104-bda3-ad86a194970318
854238enoxaparin sodium 60 MG in 0.6 ML Prefilled SyringePSN3e6bf2b3-9339-4104-bda3-ad86a194970318
854241enoxaparin sodium 80 MG in 0.8 ML Prefilled SyringePSN3e6bf2b3-9339-4104-bda3-ad86a194970318
8542280.3 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD3e6bf2b3-9339-4104-bda3-ad86a194970318
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD3e6bf2b3-9339-4104-bda3-ad86a194970318
8542380.6 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD3e6bf2b3-9339-4104-bda3-ad86a194970318
8542410.8 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD3e6bf2b3-9339-4104-bda3-ad86a194970318
8542450.8 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCD3e6bf2b3-9339-4104-bda3-ad86a194970318
8542481 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD3e6bf2b3-9339-4104-bda3-ad86a194970318
8542521 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCD3e6bf2b3-9339-4104-bda3-ad86a194970318
854255enoxaparin sodium 100 MG/ML Injectable SolutionSCD3e6bf2b3-9339-4104-bda3-ad86a194970318
8542280.3 ML ENX sodium 100 MG/ML Prefilled SyringeSY3e6bf2b3-9339-4104-bda3-ad86a194970318
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSY3e6bf2b3-9339-4104-bda3-ad86a194970318
8542380.6 ML ENX sodium 100 MG/ML Prefilled SyringeSY3e6bf2b3-9339-4104-bda3-ad86a194970318
8542410.8 ML ENX sodium 100 MG/ML Prefilled SyringeSY3e6bf2b3-9339-4104-bda3-ad86a194970318
8542450.8 ML ENX sodium 150 MG/ML Prefilled SyringeSY3e6bf2b3-9339-4104-bda3-ad86a194970318
8542481 ML ENX sodium 100 MG/ML Prefilled SyringeSY3e6bf2b3-9339-4104-bda3-ad86a194970318
8542521 ML ENX sodium 150 MG/ML Prefilled SyringeSY3e6bf2b3-9339-4104-bda3-ad86a194970318
854252enoxaparin 150 MG per 1 ML Prefilled SyringeSY3e6bf2b3-9339-4104-bda3-ad86a194970318
854248enoxaparin sodium 100 MG per 1 ML Prefilled SyringeSY3e6bf2b3-9339-4104-bda3-ad86a194970318
854245enoxaparin sodium 120 MG per 0.8 ML Prefilled SyringeSY3e6bf2b3-9339-4104-bda3-ad86a194970318
854228enoxaparin sodium 30 MG per 0.3 ML Prefilled SyringeSY3e6bf2b3-9339-4104-bda3-ad86a194970318
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSY3e6bf2b3-9339-4104-bda3-ad86a194970318
854238enoxaparin sodium 60 MG per 0.6 ML Prefilled SyringeSY3e6bf2b3-9339-4104-bda3-ad86a194970318
854241enoxaparin sodium 80 MG per 0.8 ML Prefilled SyringeSY3e6bf2b3-9339-4104-bda3-ad86a194970318
854255ENX sodium 100 MG/ML Injectable SolutionSY3e6bf2b3-9339-4104-bda3-ad86a194970318

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0548-5608-00005485608001 VIAL in 1 CARTON (0548-5608-00) / 3 mL in 1 VIAL1 vial2019-11-110000-00-00NoNoCurrent