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 Identifiers#

Field, Values table
FieldValues
Unii0JJ21K6L2I
Rxcui2663945, 2663952

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

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