Leukine (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — NDC: 71837-5843-1 — 250 mcg Lyophilized Powder for Injection Vial Label

250 mcg Lyophilized Powder for Injection Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — NDC: 71837-5843-5 — 250 mcg Lyophilized Powder for Injection 5-count Carton Label

250 mcg Lyophilized Powder for Injection 5-count Carton Label
(click image for full-size original)

LEUKINE sargramostim injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71837-5843
Route of Administration SUBCUTANEOUS, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SARGRAMOSTIM (SARGRAMOSTIM) SARGRAMOSTIM 250 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL 40 mg in 1 mL
SUCROSE 10 mg in 1 mL
TROMETHAMINE 1.2 mg in 1 mL
WATER
HYDROCHLORIC ACID
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71837-5843-5 5 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (71837-5843-1)
1 NDC:71837-5843-1 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (71837-5843-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103362 09/01/2023
Labeler — Partner Therapeutics, Inc. (080709490)
Establishment
Name Address ID/FEI Operations
Partner Therapeutics 081059614 ANALYSIS (71837-5843), API MANUFACTURE (71837-5843)

Revised: 08/2023 Partner Therapeutics, Inc.

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