Fabrazyme (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 5 mg Vial Carton

NDC 58468-0041-1 Rx only

Fabrazyme® agalsidase beta

5 mg

For Intravenous Infusion Only

One single-dose vial

Discard unused portion

SANOFI GENZYME

PRINCIPAL DISPLAY PANEL -- 5 mg Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 35 mg Vial Carton

NDC 58468-0040-1 Rx only

Fabrazyme® agalsidase beta

35 mg

For Intravenous Infusion Only

One single-dose vial

Discard unused portion

SANOFI GENZYME

PRINCIPAL DISPLAY PANEL -- 35 mg Vial Carton
(click image for full-size original)
FABRAZYME agalsidase beta injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58468-0041
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AGALSIDASE BETA (AGALSIDASE BETA) AGALSIDASE BETA 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL 33 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 3 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 8.8 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58468-0041-1 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
1 1 mL in 1 VIAL, GLASS This package is contained within the CARTON (58468-0041-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103979 12/17/2008
FABRAZYME agalsidase beta injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58468-0040
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AGALSIDASE BETA (AGALSIDASE BETA) AGALSIDASE BETA 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL 222 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 20.4 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 59.2 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58468-0040-1 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
1 7 mL in 1 VIAL, GLASS This package is contained within the CARTON (58468-0040-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103979 12/17/2008
Labeler — Genzyme Corporation (025322157)
Establishment
Name Address ID/FEI Operations
Genzyme Corporation 968278916 API MANUFACTURE (58468-0040), API MANUFACTURE (58468-0041), ANALYSIS (58468-0040), ANALYSIS (58468-0041)
Establishment
Name Address ID/FEI Operations
Genzyme Corporation 050424395 LABEL (58468-0040), LABEL (58468-0041), PACK (58468-0040), PACK (58468-0041), ANALYSIS (58468-0040), ANALYSIS (58468-0041)
Establishment
Name Address ID/FEI Operations
Genzyme Corporation 968278874 API MANUFACTURE (58468-0040), API MANUFACTURE (58468-0041)
Establishment
Name Address ID/FEI Operations
Genzyme Corporation 968278932 API MANUFACTURE (58468-0040), API MANUFACTURE (58468-0041)
Establishment
Name Address ID/FEI Operations
Genzyme Corporation 943130096 API MANUFACTURE (58468-0040), API MANUFACTURE (58468-0041), ANALYSIS (58468-0040), ANALYSIS (58468-0041)
Establishment
Name Address ID/FEI Operations
Genzyme Corporation 034378252 ANALYSIS (58468-0040), ANALYSIS (58468-0041)
Establishment
Name Address ID/FEI Operations
Genzyme Corporation 968302658 ANALYSIS (58468-0040), ANALYSIS (58468-0041)
Establishment
Name Address ID/FEI Operations
Genzyme Corporation 078456891 ANALYSIS (58468-0040), ANALYSIS (58468-0041)
Establishment
Name Address ID/FEI Operations
Genzyme Ireland 985127419 MANUFACTURE (58468-0040), MANUFACTURE (58468-0041), ANALYSIS (58468-0040), ANALYSIS (58468-0041), LABEL (58468-0040), LABEL (58468-0041), PACK (58468-0040), PACK (58468-0041)
Establishment
Name Address ID/FEI Operations
Genzyme Corporation 117450412 MANUFACTURE (58468-0040), MANUFACTURE (58468-0041), ANALYSIS (58468-0040), ANALYSIS (58468-0041)

Revised: 03/2021 Genzyme Corporation

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