Enoxaparin Sodium
These highlights do not include all the information needed to use ENOXAPARIN sodium injection, USP safely and effectively. See full prescribing information for ENOXAPARIN sodium injection, USP. ENOXAPARIN sodium injection, USP for subcutaneous use Initial U.S. Approval: 1993
Approved
Approval ID
014c6710-f2c4-fd1e-e063-6394a90ae525
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 30, 2023
Manufacturers
FDA
NorthStar RxLLC
DUNS: 830546433
Products 7
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Enoxaparin Sodium
PRODUCT DETAILS
NDC Product Code72603-225
Application NumberANDA205660
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 30, 2023
Generic NameEnoxaparin Sodium
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ENOXAPARIN SODIUMActive
Quantity: 150 mg in 1 mL
Code: 8NZ41MIK1O
Classification: ACTIB
Enoxaparin Sodium
PRODUCT DETAILS
NDC Product Code72603-205
Application NumberANDA205660
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 30, 2023
Generic NameEnoxaparin Sodium
INGREDIENTS (2)
ENOXAPARIN SODIUMActive
Quantity: 100 mg in 1 mL
Code: 8NZ41MIK1O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Enoxaparin Sodium
PRODUCT DETAILS
NDC Product Code72603-185
Application NumberANDA205660
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 30, 2023
Generic NameEnoxaparin Sodium
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ENOXAPARIN SODIUMActive
Quantity: 60 mg in 0.6 mL
Code: 8NZ41MIK1O
Classification: ACTIB
Enoxaparin Sodium
PRODUCT DETAILS
NDC Product Code72603-195
Application NumberANDA205660
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 30, 2023
Generic NameEnoxaparin Sodium
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ENOXAPARIN SODIUMActive
Quantity: 80 mg in 0.8 mL
Code: 8NZ41MIK1O
Classification: ACTIB
Enoxaparin Sodium
PRODUCT DETAILS
NDC Product Code72603-215
Application NumberANDA205660
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 30, 2023
Generic NameEnoxaparin Sodium
INGREDIENTS (2)
ENOXAPARIN SODIUMActive
Quantity: 120 mg in 0.8 mL
Code: 8NZ41MIK1O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Enoxaparin Sodium
PRODUCT DETAILS
NDC Product Code72603-175
Application NumberANDA205660
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 30, 2023
Generic NameEnoxaparin Sodium
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ENOXAPARIN SODIUMActive
Quantity: 40 mg in 0.4 mL
Code: 8NZ41MIK1O
Classification: ACTIB
Enoxaparin Sodium
PRODUCT DETAILS
NDC Product Code72603-165
Application NumberANDA205660
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 30, 2023
Generic NameEnoxaparin Sodium
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ENOXAPARIN SODIUMActive
Quantity: 30 mg in 0.3 mL
Code: 8NZ41MIK1O
Classification: ACTIB