FDA.reportPublic FDA data

ZALTRAP

Product NDC
0024-5840
11-digit product format
000245840
Labeler code
0024
Product ID
0024-5840_14431dcb-cda7-4ae4-aa2b-6480d6ac459f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziv-aflibercept
Dosage form
SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
sanofi-aventis U.S. LLC
Application
BLA125418
Marketing category
BLA
Marketing start
2012-08-03
Substance
AFLIBERCEPT
Active strength
100 mg/4mL
Pharmacologic classes
Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZALTRAP
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AFLIBERCEPT100 mg/4mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15C2VL427D
Rxcui1723187, 1723189, 1723193, 1723194

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
45d073be-8495-4765-a25a-358ca5c6ee13Product name120250516
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
f7afb9c5-b366-4c4e-a112-2c667c0bcd8eProduct name120190807
71c97ffd-612a-44e6-8307-e1fe87b9db9cProduct name120150923
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0024-5840-01ZALTRAP4 mL in 1 VIALSOLUTION, CONCENTRATE428
0024-5840-01ZALTRAP1 in 1 CARTONSOLUTION, CONCENTRATE128
0024-5840-03ZALTRAP3 in 1 CARTONSOLUTION, CONCENTRATE328
0024-5840-03ZALTRAP4 mL in 1 VIALSOLUTION, CONCENTRATE428

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-5840-01ML - Milliliter0024-5840d09d639c-e837-484f-97ec-ba7a755a2ae212013-02-13
0024-5840-03ML - Milliliter0024-584080d64186-d473-4d78-baa3-3743effdc70a12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
afliberceptACTIVE INGREDIENT15C2VL427DZALTRAP (ZIV-AFLIBERCEPT) SOLUTION, CONCENTRATE [SANOFI-AVENTIS U.S. LLC]14
afliberceptACTIVE MOIETY15C2VL427DZALTRAP (ZIV-AFLIBERCEPT) SOLUTION, CONCENTRATE [SANOFI-AVENTIS U.S. LLC]14
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPZALTRAP (ZIV-AFLIBERCEPT) SOLUTION, CONCENTRATE [SANOFI-AVENTIS U.S. LLC]14
hydrochloric acidINACTIVE INGREDIENTQTT17582CBZALTRAP (ZIV-AFLIBERCEPT) SOLUTION, CONCENTRATE [SANOFI-AVENTIS U.S. LLC]14
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHZALTRAP (ZIV-AFLIBERCEPT) SOLUTION, CONCENTRATE [SANOFI-AVENTIS U.S. LLC]14
sodium chlorideINACTIVE INGREDIENT451W47IQ8XZALTRAP (ZIV-AFLIBERCEPT) SOLUTION, CONCENTRATE [SANOFI-AVENTIS U.S. LLC]14
sodium hydroxideINACTIVE INGREDIENT55X04QC32IZALTRAP (ZIV-AFLIBERCEPT) SOLUTION, CONCENTRATE [SANOFI-AVENTIS U.S. LLC]14
sodium phosphate, dibasic, heptahydrateINACTIVE INGREDIENT70WT22SF4BZALTRAP (ZIV-AFLIBERCEPT) SOLUTION, CONCENTRATE [SANOFI-AVENTIS U.S. LLC]14
sodium phosphate, monobasic, monohydrateINACTIVE INGREDIENT593YOG76RNZALTRAP (ZIV-AFLIBERCEPT) SOLUTION, CONCENTRATE [SANOFI-AVENTIS U.S. LLC]14
sucroseINACTIVE INGREDIENTC151H8M554ZALTRAP (ZIV-AFLIBERCEPT) SOLUTION, CONCENTRATE [SANOFI-AVENTIS U.S. LLC]14
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KZALTRAP (ZIV-AFLIBERCEPT) SOLUTION, CONCENTRATE [SANOFI-AVENTIS U.S. LLC]14
waterINACTIVE INGREDIENT059QF0KO0RZALTRAP (ZIV-AFLIBERCEPT) SOLUTION, CONCENTRATE [SANOFI-AVENTIS U.S. LLC]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-5840ZALTRAP (ZIV-AFLIBERCEPT) SOLUTION, CONCENTRATE [SANOFI-AVENTIS U.S. LLC]27Current NDC, Legacy NDC, 4 package rows20250523_f6725df6-50ee-4b0a-b900-d02ba634395d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723194ZALTRAP 100 MG in 4 ML InjectionPSNf6725df6-50ee-4b0a-b900-d02ba634395d28
1723189ZALTRAP 200 MG in 8 ML InjectionPSNf6725df6-50ee-4b0a-b900-d02ba634395d28
1723193ziv-aflibercept 100 MG in 4 ML InjectionPSNf6725df6-50ee-4b0a-b900-d02ba634395d28
1723187ziv-aflibercept 200 MG in 8 ML InjectionPSNf6725df6-50ee-4b0a-b900-d02ba634395d28
17231944 ML ziv-aflibercept 25 MG/ML Injection [Zaltrap]SBDf6725df6-50ee-4b0a-b900-d02ba634395d28
17231898 ML ziv-aflibercept 25 MG/ML Injection [Zaltrap]SBDf6725df6-50ee-4b0a-b900-d02ba634395d28
17231934 ML ziv-aflibercept 25 MG/ML InjectionSCDf6725df6-50ee-4b0a-b900-d02ba634395d28
17231878 ML ziv-aflibercept 25 MG/ML InjectionSCDf6725df6-50ee-4b0a-b900-d02ba634395d28
17231944 ML Zaltrap 25 MG/ML InjectionSYf6725df6-50ee-4b0a-b900-d02ba634395d28
17231898 ML Zaltrap 25 MG/ML InjectionSYf6725df6-50ee-4b0a-b900-d02ba634395d28
1723194Zaltrap 100 MG per 4 ML InjectionSYf6725df6-50ee-4b0a-b900-d02ba634395d28
1723189Zaltrap 200 MG per 8 ML InjectionSYf6725df6-50ee-4b0a-b900-d02ba634395d28
1723193ziv-aflibercept 100 MG per 4 ML InjectionSYf6725df6-50ee-4b0a-b900-d02ba634395d28
1723187ziv-aflibercept 200 MG per 8 ML InjectionSYf6725df6-50ee-4b0a-b900-d02ba634395d28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0024-5840-01000245840011 VIAL in 1 CARTON (0024-5840-01) / 4 mL in 1 VIAL1 vial2012-08-030000-00-00NoNoCurrent
0024-5840-03000245840033 in 1 CARTONHistorical