FDA.reportPublic FDA data

Enoxaparin Sodium

Product NDC
71288-436
11-digit product format
712880436
Labeler code
71288
Product ID
71288-436_6f7ce651-e9dd-4c6b-a63c-1d911d63222a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enoxaparin Sodium
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Meitheal Pharmaceuticals Inc.
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
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 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
71288-436-88Enoxaparin Sodium1 mL in 1 SYRINGEINJECTION14
71288-436-89Enoxaparin Sodium10 in 1 CARTONINJECTION104
71288-436-91Enoxaparin Sodium1 mL in 1 SYRINGEINJECTION13
71288-436-92Enoxaparin Sodium10 in 1 CARTONINJECTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-436ENOXAPARIN SODIUM INJECTION [MEITHEAL PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20230527_adbba7bb-fa72-4cec-aa69-13965591a45d.zip
71288-436ENOXAPARIN SODIUM INJECTION [MEITHEAL PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 2 package rows20230527_b6fb85ab-1fe5-4dd3-a97f-adbed0674f67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854248enoxaparin sodium 100 MG in 1 ML Prefilled SyringePSNadbba7bb-fa72-4cec-aa69-13965591a45d4
854245enoxaparin sodium 120 MG in 0.8 ML Prefilled SyringePSNadbba7bb-fa72-4cec-aa69-13965591a45d4
854252enoxaparin sodium 150 MG in 1 ML Prefilled SyringePSNadbba7bb-fa72-4cec-aa69-13965591a45d4
854228enoxaparin sodium 30 MG in 0.3 ML Prefilled SyringePSNadbba7bb-fa72-4cec-aa69-13965591a45d4
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSNadbba7bb-fa72-4cec-aa69-13965591a45d4
854238enoxaparin sodium 60 MG in 0.6 ML Prefilled SyringePSNadbba7bb-fa72-4cec-aa69-13965591a45d4
854241enoxaparin sodium 80 MG in 0.8 ML Prefilled SyringePSNadbba7bb-fa72-4cec-aa69-13965591a45d4
8542280.3 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDadbba7bb-fa72-4cec-aa69-13965591a45d4
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDadbba7bb-fa72-4cec-aa69-13965591a45d4
8542380.6 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDadbba7bb-fa72-4cec-aa69-13965591a45d4
8542410.8 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDadbba7bb-fa72-4cec-aa69-13965591a45d4
8542450.8 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCDadbba7bb-fa72-4cec-aa69-13965591a45d4
8542481 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDadbba7bb-fa72-4cec-aa69-13965591a45d4
8542521 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCDadbba7bb-fa72-4cec-aa69-13965591a45d4
8542280.3 ML ENX sodium 100 MG/ML Prefilled SyringeSYadbba7bb-fa72-4cec-aa69-13965591a45d4
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSYadbba7bb-fa72-4cec-aa69-13965591a45d4
8542380.6 ML ENX sodium 100 MG/ML Prefilled SyringeSYadbba7bb-fa72-4cec-aa69-13965591a45d4
8542410.8 ML ENX sodium 100 MG/ML Prefilled SyringeSYadbba7bb-fa72-4cec-aa69-13965591a45d4
8542450.8 ML ENX sodium 150 MG/ML Prefilled SyringeSYadbba7bb-fa72-4cec-aa69-13965591a45d4
8542481 ML ENX sodium 100 MG/ML Prefilled SyringeSYadbba7bb-fa72-4cec-aa69-13965591a45d4
8542521 ML ENX sodium 150 MG/ML Prefilled SyringeSYadbba7bb-fa72-4cec-aa69-13965591a45d4
854252enoxaparin 150 MG per 1 ML Prefilled SyringeSYadbba7bb-fa72-4cec-aa69-13965591a45d4
854248enoxaparin sodium 100 MG per 1 ML Prefilled SyringeSYadbba7bb-fa72-4cec-aa69-13965591a45d4
854245enoxaparin sodium 120 MG per 0.8 ML Prefilled SyringeSYadbba7bb-fa72-4cec-aa69-13965591a45d4
854228enoxaparin sodium 30 MG per 0.3 ML Prefilled SyringeSYadbba7bb-fa72-4cec-aa69-13965591a45d4
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSYadbba7bb-fa72-4cec-aa69-13965591a45d4
854238enoxaparin sodium 60 MG per 0.6 ML Prefilled SyringeSYadbba7bb-fa72-4cec-aa69-13965591a45d4
854241enoxaparin sodium 80 MG per 0.8 ML Prefilled SyringeSYadbba7bb-fa72-4cec-aa69-13965591a45d4
854248enoxaparin sodium 100 MG in 1 ML Prefilled SyringePSNb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
854245enoxaparin sodium 120 MG in 0.8 ML Prefilled SyringePSNb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
854252enoxaparin sodium 150 MG in 1 ML Prefilled SyringePSNb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
854228enoxaparin sodium 30 MG in 0.3 ML Prefilled SyringePSNb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSNb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
854238enoxaparin sodium 60 MG in 0.6 ML Prefilled SyringePSNb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
854241enoxaparin sodium 80 MG in 0.8 ML Prefilled SyringePSNb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
8542280.3 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
8542380.6 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
8542410.8 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
8542450.8 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCDb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
8542481 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
8542521 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCDb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
8542280.3 ML ENX sodium 100 MG/ML Prefilled SyringeSYb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSYb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
8542380.6 ML ENX sodium 100 MG/ML Prefilled SyringeSYb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
8542410.8 ML ENX sodium 100 MG/ML Prefilled SyringeSYb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
8542450.8 ML ENX sodium 150 MG/ML Prefilled SyringeSYb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
8542481 ML ENX sodium 100 MG/ML Prefilled SyringeSYb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
8542521 ML ENX sodium 150 MG/ML Prefilled SyringeSYb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
854252enoxaparin 150 MG per 1 ML Prefilled SyringeSYb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
854248enoxaparin sodium 100 MG per 1 ML Prefilled SyringeSYb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
854245enoxaparin sodium 120 MG per 0.8 ML Prefilled SyringeSYb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
854228enoxaparin sodium 30 MG per 0.3 ML Prefilled SyringeSYb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSYb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
854238enoxaparin sodium 60 MG per 0.6 ML Prefilled SyringeSYb6fb85ab-1fe5-4dd3-a97f-adbed0674f673
854241enoxaparin sodium 80 MG per 0.8 ML Prefilled SyringeSYb6fb85ab-1fe5-4dd3-a97f-adbed0674f673

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-436-88712880436881 mL in 1 SYRINGE1 mlHistorical
71288-436-897128804368910 SYRINGE in 1 CARTON (71288-436-89) / 1 mL in 1 SYRINGE (71288-436-88) 10 syringe2019-12-010000-00-00NoNoCurrent
71288-436-91712880436911 mL in 1 SYRINGE1 mlHistorical
71288-436-927128804369210 SYRINGE in 1 CARTON (71288-436-92) / 1 mL in 1 SYRINGE (71288-436-91) 10 syringe2019-12-01NoNoCurrent