Fragmin
These highlights do not include all the information needed to use FRAGMIN safely and effectively. See full prescribing information for FRAGMIN. FRAGMIN (dalteparin sodium) injection, USP, for subcutaneous use Initial U.S. Approval: 1994
Approved
Approval ID
23527b8b-9b28-4e6d-9751-33b143975ac7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 16, 2023
Manufacturers
FDA
Pfizer Laboratories Div Pfizer Inc
DUNS: 134489525
Products 9
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dalteparin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-0253
Application NumberNDA020287
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dalteparin Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 15, 2022
FDA Product Classification
INGREDIENTS (3)
DALTEPARIN SODIUMActive
Quantity: 2500 [iU] in 1 mL
Code: 12M44VTJ7B
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
Dalteparin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-0223
Application NumberNDA020287
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dalteparin Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 15, 2022
FDA Product Classification
INGREDIENTS (3)
DALTEPARIN SODIUMActive
Quantity: 15000 [iU] in 0.6 mL
Code: 12M44VTJ7B
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
Dalteparin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-0232
Application NumberNDA020287
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dalteparin Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 15, 2022
FDA Product Classification
INGREDIENTS (3)
DALTEPARIN SODIUMActive
Quantity: 25000 [iU] in 1 mL
Code: 12M44VTJ7B
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 14 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
Dalteparin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-0206
Application NumberNDA020287
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dalteparin Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 15, 2022
FDA Product Classification
INGREDIENTS (3)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
DALTEPARIN SODIUMActive
Quantity: 7500 [iU] in 0.3 mL
Code: 12M44VTJ7B
Classification: ACTIB
Dalteparin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-0195
Application NumberNDA020287
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dalteparin Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 15, 2022
FDA Product Classification
INGREDIENTS (3)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DALTEPARIN SODIUMActive
Quantity: 2500 [iU] in 0.2 mL
Code: 12M44VTJ7B
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
Dalteparin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-0220
Application NumberNDA020287
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dalteparin Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 15, 2022
FDA Product Classification
INGREDIENTS (3)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DALTEPARIN SODIUMActive
Quantity: 12500 [iU] in 0.5 mL
Code: 12M44VTJ7B
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
Dalteparin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-0217
Application NumberNDA020287
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dalteparin Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 15, 2022
FDA Product Classification
INGREDIENTS (3)
DALTEPARIN SODIUMActive
Quantity: 10000 [iU] in 1 mL
Code: 12M44VTJ7B
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Dalteparin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-0196
Application NumberNDA020287
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dalteparin Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 15, 2022
FDA Product Classification
INGREDIENTS (3)
DALTEPARIN SODIUMActive
Quantity: 5000 [iU] in 0.2 mL
Code: 12M44VTJ7B
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Dalteparin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-0228
Application NumberNDA020287
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dalteparin Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 15, 2022
FDA Product Classification
INGREDIENTS (3)
DALTEPARIN SODIUMActive
Quantity: 18000 [iU] in 0.72 mL
Code: 12M44VTJ7B
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT