Prescription Drug Information: ZALTRAP (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 200 mg/8 mL Vial Carton

NDC 0024-5841-01

ZALTRAP®
(ziv-aflibercept)
Injection for
Intravenous Infusion

200 mg/8 mL
(25 mg/mL)

For intravenous infusion only.
Not to be administered by
other routes.
Hyperosmotic, must be diluted.

Single-dose vial.Discard unused portion

Rx ONLY

SANOFI

PRINCIPAL DISPLAY PANEL -- 200 mg/8 mL Vial Carton
(click image for full-size original)
ZALTRAP ziv-aflibercept solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0024-5840
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AFLIBERCEPT (AFLIBERCEPT) AFLIBERCEPT 100 mg in 4 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE
SODIUM CHLORIDE
TRISODIUM CITRATE DIHYDRATE
CITRIC ACID MONOHYDRATE
POLYSORBATE 20
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0024-5840-01 1 VIAL in 1 CARTON contains a VIAL
1 4 mL in 1 VIAL This package is contained within the CARTON (0024-5840-01)
2 NDC:0024-5840-03 3 VIAL in 1 CARTON contains a VIAL
2 4 mL in 1 VIAL This package is contained within the CARTON (0024-5840-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125418 08/03/2012
ZALTRAP ziv-aflibercept solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0024-5841
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AFLIBERCEPT (AFLIBERCEPT) AFLIBERCEPT 200 mg in 8 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE
SODIUM CHLORIDE
TRISODIUM CITRATE DIHYDRATE
CITRIC ACID MONOHYDRATE
POLYSORBATE 20
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0024-5841-01 1 VIAL in 1 CARTON contains a VIAL
1 8 mL in 1 VIAL This package is contained within the CARTON (0024-5841-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125418 08/03/2012
Labeler — sanofi-aventis U.S. LLC (824676584)
Establishment
Name Address ID/FEI Operations
Regeneron Pharmaceuticals, Inc. 945589711 ANALYSIS (0024-5840), ANALYSIS (0024-5841), API MANUFACTURE (0024-5840), API MANUFACTURE (0024-5841)
Establishment
Name Address ID/FEI Operations
Sanofi-Aventis Deutschland GmbH 313218430 ANALYSIS (0024-5840), ANALYSIS (0024-5841), LABEL (0024-5840), LABEL (0024-5841), MANUFACTURE (0024-5840), MANUFACTURE (0024-5841), PACK (0024-5840), PACK (0024-5841)

Revised: 03/2020 sanofi-aventis U.S. LLC

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