NDC Code(s) : 68982-820-81, 68982-820-01, 68982-820-82, 68982-820-02, 68982-820-83, 68982-820-03, 68982-820-84, 68982-820-04, 68982-820-85, 68982-820-05, 68982-820-86, 68982-820-06
Packager : Octapharma USA Inc

Category : PLASMA DERIVATIVE

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Panzygaimmune globulin intravenous (human) SOLUTION
Product Information
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:68982-820
Route of Administration Intravenous DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMAN IMMUNOGLOBULIN G(UNII: 66Y330CJHS)
(HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS) 		HUMAN IMMUNOGLOBULIN G100 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68982-820-011 in 1 CARTON
1NDC:68982-820-8110 mL in 1 BOTTLE, GLASS Type 0: Not a Combination Product
2NDC:68982-820-021 in 1 CARTON
2NDC:68982-820-8225 mL in 1 BOTTLE, GLASS Type 0: Not a Combination Product
3NDC:68982-820-031 in 1 CARTON
3NDC:68982-820-8350 mL in 1 BOTTLE, GLASS Type 0: Not a Combination Product
4NDC:68982-820-041 in 1 CARTON
4NDC:68982-820-84100 mL in 1 BOTTLE, GLASS Type 0: Not a Combination Product
5NDC:68982-820-051 in 1 CARTON
5NDC:68982-820-85200 mL in 1 BOTTLE, GLASS Type 0: Not a Combination Product
6NDC:68982-820-061 in 1 CARTON
6NDC:68982-820-86300 mL in 1 BOTTLE, GLASS Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125587 11/12/2018

LABELER - Octapharma USA Inc(606121163)

PRINCIPAL DISPLAY PANEL


PACKAGE LABEL – PRINCIPAL DISPLAY PANEL


Immune Globulin Intravenous (Human) - ifas, 10%


Panzyga

10 mL

NDC 68982-820-01


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Panzyga

25 mL

NDC 68982-820-02


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Panzyga

50 mL

NDC 68982-820-03


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Panzyga

100 mL

NDC 68982-820-04


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Panzyga

200 mL

NDC 68982-820-05


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Panzyga

300 mL

NDC 68982-820-06


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