FDA.reportPublic FDA data

Enoxaparin Sodium

Product NDC
71288-426
11-digit product format
712880426
Labeler code
71288
Product ID
71288-426_72e0f228-ca47-4296-bd53-7e5ca00eb922
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enoxaparin Sodium
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA214856
Marketing category
ANDA
Marketing start
2022-06-14
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
Rxcui854255

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
71288-426-03Enoxaparin Sodium1 in 1 CARTONINJECTION16
71288-426-03Enoxaparin Sodium3 mL in 1 VIAL, MULTI-DOSEINJECTION36
71288-426-91Enoxaparin Sodium1 in 1 CARTONINJECTION11
71288-426-91Enoxaparin Sodium3 mL in 1 VIAL, MULTI-DOSEINJECTION31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-426-03ML - Milliliter71288-42606d9d397-37ae-474d-abe4-7577fb1eac9a12022-09-12
71288-426-91ML - Milliliter71288-4268affdfd2-a839-4a69-8535-03eb6add8c7712024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-426ENOXAPARIN SODIUM INJECTION [MEITHEAL PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 2 package rows20241208_7d38c307-767f-4c38-ac0e-b8bb62782602.zip
71288-426ENOXAPARIN SODIUM INJECTION [MEITHEAL PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 2 package rows20240206_adfc2b23-00a5-4f05-a08b-83087e1e4843.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854255enoxaparin sodium 100 MG/ML Injectable SolutionPSN7d38c307-767f-4c38-ac0e-b8bb627826026
854255enoxaparin sodium 100 MG/ML Injectable SolutionSCD7d38c307-767f-4c38-ac0e-b8bb627826026
854255ENX sodium 100 MG/ML Injectable SolutionSY7d38c307-767f-4c38-ac0e-b8bb627826026
854255enoxaparin sodium 100 MG/ML Injectable SolutionPSNadfc2b23-00a5-4f05-a08b-83087e1e48431
854255enoxaparin sodium 100 MG/ML Injectable SolutionSCDadfc2b23-00a5-4f05-a08b-83087e1e48431
854255ENX sodium 100 MG/ML Injectable SolutionSYadfc2b23-00a5-4f05-a08b-83087e1e48431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71288-426-03712880426031 VIAL, MULTI-DOSE in 1 CARTON (71288-426-03) / 3 mL in 1 VIAL, MULTI-DOSE2022-06-140000-00-00NoNoCurrent
71288-426-91712880426911 VIAL, MULTI-DOSE in 1 CARTON (71288-426-91) / 3 mL in 1 VIAL, MULTI-DOSE2022-06-14NoNoHistorical