FDA.reportPublic FDA data

VEOPOZ

Product NDC
61755-014
11-digit product format
617550014
Labeler code
61755
Product ID
61755-014_a8be5cf0-49ba-4795-a2e5-7ea07f495958
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pozelimab
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Regeneron Pharmaceuticals, Inc.
Application
BLA761339
Marketing category
BLA
Marketing start
2023-08-18
Substance
POZELIMAB
Active strength
200 mg/mL
Pharmacologic classes
Complement Inhibitor [EPC], Complement 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
VEOPOZ
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POZELIMAB200 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0JJ21K6L2IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2663945Internal RxNorm lookup
2663952Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a8d6f10e-9430-450a-a3dd-b538f9b2a308Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
139e2f80-4658-4db5-a3db-6f97e3c522daProduct name120250516
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61755-014-00VEOPOZ2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION26
61755-014-01VEOPOZ1 in 1 CARTONINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61755-014-00ML - Milliliter61755-0148a6a2bee-4188-4faa-916b-738c42ea0ee312024-07-12
61755-014-01ML - Milliliter61755-014badeff19-cd7e-435d-8e2a-71f02a28127012023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61755-014VEOPOZ (POZELIMAB) INJECTION, SOLUTION [REGENERON PHARMACEUTICALS, INC.]5Current NDC, 2 package rows20240322_a8d6f10e-9430-450a-a3dd-b538f9b2a308.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
VEOPOZPOZELIMABRegeneron Pharmaceuticals, Inc.a8d6f10e-9430-450a-a3dd-b538f9b2a3082025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761339
ndc (product): 61755-014

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761339Veopozpozelimab-bbfg351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2663945pozelimab-bbfg 400 MG in 2 ML InjectionPSNa8d6f10e-9430-450a-a3dd-b538f9b2a3086
2663952Veopoz 400 MG in 2 ML InjectionPSNa8d6f10e-9430-450a-a3dd-b538f9b2a3086
26639522 ML pozelimab-bbfg 200 MG/ML Injection [Veopoz]SBDa8d6f10e-9430-450a-a3dd-b538f9b2a3086
26639452 ML pozelimab-bbfg 200 MG/ML InjectionSCDa8d6f10e-9430-450a-a3dd-b538f9b2a3086
2663945pozelimab-bbfg 400 MG per 2 ML InjectionSYa8d6f10e-9430-450a-a3dd-b538f9b2a3086
2663952Veopoz 400 MG per 2 ML InjectionSYa8d6f10e-9430-450a-a3dd-b538f9b2a3086

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61755-014-00617550014002 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
61755-014-01617550014011 VIAL, SINGLE-DOSE in 1 CARTON (61755-014-01) / 2 mL in 1 VIAL, SINGLE-DOSE (61755-014-00) 2023-08-18NoNoCurrent