Neupogen
Approved
Approval ID
3bc802bd-76b4-4f45-8571-a436ec26228e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 2, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
filgrastim
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-2522
Application NumberBLA103353
Product Classification
M
Marketing Category
C73585
G
Generic Name
filgrastim
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 2, 2009
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.04 mg in 1.0 mL
Code: 6OZP39ZG8H
Classification: IACT
SODIUM POLYMETAPHOSPHATEInactive
Quantity: 0.035 mg in 1.0 mL
Code: P1BM4ZH95L
Classification: IACT
FILGRASTIMActive
Quantity: 300 ug in 1 mL
Code: PVI5M0M1GW
Classification: ACTIB
SORBITOLInactive
Quantity: 50.0 mg in 1.0 mL
Code: 506T60A25R
Classification: IACT
filgrastim
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3050
Application NumberBLA103353
Product Classification
M
Marketing Category
C73585
G
Generic Name
filgrastim
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 2, 2009
FDA Product Classification
INGREDIENTS (5)
FILGRASTIMActive
Quantity: 480 ug in 0.8 mL
Code: PVI5M0M1GW
Classification: ACTIB
POLYSORBATE 80Inactive
Quantity: 0.32 mg in 0.8 mL
Code: 6OZP39ZG8H
Classification: IACT
SORBITOLInactive
Quantity: 40.0 mg in 0.8 mL
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM POLYMETAPHOSPHATEInactive
Quantity: 0.028 mg in 0.8 mL
Code: P1BM4ZH95L
Classification: IACT
filgrastim
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5020
Application NumberBLA103353
Product Classification
M
Marketing Category
C73585
G
Generic Name
filgrastim
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 2, 2009
FDA Product Classification
INGREDIENTS (5)
FILGRASTIMActive
Quantity: 300 ug in 0.5 mL
Code: PVI5M0M1GW
Classification: ACTIB
POLYSORBATE 80Inactive
Quantity: 0.02 mg in 0.5 mL
Code: 6OZP39ZG8H
Classification: IACT
SODIUM POLYMETAPHOSPHATEInactive
Quantity: 0.0175 mg in 0.5 mL
Code: P1BM4ZH95L
Classification: IACT
SORBITOLInactive
Quantity: 25.0 mg in 0.5 mL
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT