FDA.reportPublic FDA data

ZALTRAP

Product NDC
0024-5841
11-digit product format
000245841
Labeler code
0024
Product ID
0024-5841_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
200 mg/8mL
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
AFLIBERCEPT200 mg/8mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15C2VL427DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1723187Internal RxNorm lookup
1723189Internal RxNorm lookup
1723193Internal RxNorm lookup
1723194Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f6725df6-50ee-4b0a-b900-d02ba634395dAvailable on FDA.report

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
0024-5841-01ZALTRAP1 in 1 CARTONSOLUTION, CONCENTRATE128
0024-5841-01ZALTRAP8 mL in 1 VIALSOLUTION, CONCENTRATE828

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-5841-01ML - Milliliter0024-5841d8a4e8b0-abef-4c61-9449-d7f66efbbb5812013-02-13

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
0024-5841ZALTRAP (ZIV-AFLIBERCEPT) SOLUTION, CONCENTRATE [SANOFI-AVENTIS U.S. LLC]27Current NDC, Legacy NDC, 2 package rows20250523_f6725df6-50ee-4b0a-b900-d02ba634395d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZALTRAPZIV-AFLIBERCEPTsanofi-aventis U.S. LLCf6725df6-50ee-4b0a-b900-d02ba634395d2025-10-06Warnings, Adverse reactionsExact identifier
application number: BLA125418
ndc (product): 0024-5841

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125418ZaltrapZiv-Aflibercept351(a)Rx2026-06-01

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
0024-5841-01000245841011 VIAL in 1 CARTON (0024-5841-01) / 8 mL in 1 VIAL1 vial2012-08-030000-00-00NoNoCurrent