NDC Code(s) : 70121-1754-7, 70121-1754-1, 70121-1755-7, 70121-1755-1
Packager : Amneal Pharmaceuticals LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ALYMSYSbevacizumab-maly INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70121-1754
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BEVACIZUMAB(UNII: 2S9ZZM9Q9V)
(BEVACIZUMAB - UNII:2S9ZZM9Q9V) 		BEVACIZUMAB100 mg in 4 mL
Inactive Ingredients
Ingredient Name Strength
TREHALOSE DIHYDRATE(UNII: 7YIN7J07X4)240 mg in 4 mL
POLYSORBATE 20(UNII: 7T1F30V5YH)1.6 mg in 4 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: 22ADO53M6F)4.8 mg in 4 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE(UNII: 593YOG76RN)23.2 mg in 4 mL
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70121-1754-710 in 1 CARTON 15/04/2022
14 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:70121-1754-11 in 1 CARTON 15/04/2022
24 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761231 04/15/2022
ALYMSYSbevacizumab-maly INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70121-1755
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BEVACIZUMAB(UNII: 2S9ZZM9Q9V)
(BEVACIZUMAB - UNII:2S9ZZM9Q9V) 		BEVACIZUMAB400 mg in 16 mL
Inactive Ingredients
Ingredient Name Strength
TREHALOSE DIHYDRATE(UNII: 7YIN7J07X4)960 mg in 16 mL
POLYSORBATE 20(UNII: 7T1F30V5YH)6.4 mg in 16 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: 22ADO53M6F)19.2 mg in 16 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE(UNII: 593YOG76RN)92.8 mg in 16 mL
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70121-1755-710 in 1 CARTON 15/04/2022
116 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:70121-1755-11 in 1 CARTON 15/04/2022
216 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761231 04/15/2022

LABELER - Amneal Pharmaceuticals LLC(827748190)

Establishment
Name Address ID/FEI Business Operations
Universal Farma SL 468272833 analysis(70121-1754, 70121-1755), manufacture(70121-1754, 70121-1755), sterilize(70121-1754, 70121-1755)

PRINCIPAL DISPLAY PANEL

100 mg label

PRINCIPAL DISPLAY PANEL

100mg carton

PRINCIPAL DISPLAY PANEL

400mg label

PRINCIPAL DISPLAY PANEL

400mg carton