Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Pfizer Health AB
Pfizer Laboratories Div Pfizer Inc
354433591
Pfizer Manufacturing Belgium NV
Pfizer Laboratories Div Pfizer Inc
370156507
Products9
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fragmin
Product Details
NDC Product Code
0069-0253Application Number
NDA020287Marketing Category
NDA (C73594)Route of Administration
SUBCUTANEOUSEffective Date
August 15, 2022DalteparinActive
Code: 12M44VTJ7BClass: ACTIBQuantity: 2500 [iU] in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
Fragmin
Product Details
NDC Product Code
0069-0223Application Number
NDA020287Marketing Category
NDA (C73594)Route of Administration
SUBCUTANEOUSEffective Date
August 15, 2022DalteparinActive
Code: 12M44VTJ7BClass: ACTIBQuantity: 15000 [iU] in 0.6 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
Fragmin
Product Details
NDC Product Code
0069-0232Application Number
NDA020287Marketing Category
NDA (C73594)Route of Administration
SUBCUTANEOUSEffective Date
August 15, 2022DalteparinActive
Code: 12M44VTJ7BClass: ACTIBQuantity: 25000 [iU] in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 14 mg in 1 mL
Fragmin
Product Details
NDC Product Code
0069-0206Application Number
NDA020287Marketing Category
NDA (C73594)Route of Administration
SUBCUTANEOUSEffective Date
August 15, 2022WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
DalteparinActive
Code: 12M44VTJ7BClass: ACTIBQuantity: 7500 [iU] in 0.3 mL
Fragmin
Product Details
NDC Product Code
0069-0195Application Number
NDA020287Marketing Category
NDA (C73594)Route of Administration
SUBCUTANEOUSEffective Date
August 15, 2022WATERInactive
Code: 059QF0KO0RClass: IACT
DalteparinActive
Code: 12M44VTJ7BClass: ACTIBQuantity: 2500 [iU] in 0.2 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
Fragmin
Product Details
NDC Product Code
0069-0220Application Number
NDA020287Marketing Category
NDA (C73594)Route of Administration
SUBCUTANEOUSEffective Date
August 15, 2022WATERInactive
Code: 059QF0KO0RClass: IACT
DalteparinActive
Code: 12M44VTJ7BClass: ACTIBQuantity: 12500 [iU] in 0.5 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
Fragmin
Product Details
NDC Product Code
0069-0217Application Number
NDA020287Marketing Category
NDA (C73594)Route of Administration
SUBCUTANEOUSEffective Date
August 15, 2022DalteparinActive
Code: 12M44VTJ7BClass: ACTIBQuantity: 10000 [iU] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Fragmin
Product Details
NDC Product Code
0069-0196Application Number
NDA020287Marketing Category
NDA (C73594)Route of Administration
SUBCUTANEOUSEffective Date
August 15, 2022DalteparinActive
Code: 12M44VTJ7BClass: ACTIBQuantity: 5000 [iU] in 0.2 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Fragmin
Product Details
NDC Product Code
0069-0228Application Number
NDA020287Marketing Category
NDA (C73594)Route of Administration
SUBCUTANEOUSEffective Date
August 15, 2022DalteparinActive
Code: 12M44VTJ7BClass: ACTIBQuantity: 18000 [iU] in 0.72 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT