FDA.reportPublic FDA data

Inmazeb

Product NDC
61755-019
11-digit product format
617550019
Labeler code
61755
Product ID
61755-019_03d5650a-82d9-4af5-9515-ea52c93733ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atoltivimab, maftivimab, and odesivimab-ebgn
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Regeneron Pharmaceuticals, Inc.
Application
BLA761169
Marketing category
BLA
Marketing start
2021-07-29
Substance
ATOLTIVIMAB; MAFTIVIMAB; ODESIVIMAB
Active strength
483.3; 483.3; 483.3 mg/14.5mL; mg/14.5mL; mg/14.5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOLTIVIMAB483.3 mg/14.5mL
MAFTIVIMAB483.3 mg/14.5mL
ODESIVIMAB483.3 mg/14.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FJZ07Q63VYInternal UNII lookup
KOP95331M4Internal UNII lookup
UY9LQ8P6HWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2461536Internal RxNorm lookup
2461539Internal RxNorm lookup
2571682Internal RxNorm lookup
2571685Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0536b6fe-6fe5-4fd6-8cc6-1b481945c1faAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
df703147-8958-4375-be27-b042414400aaProduct name120210513
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61755-019-00Inmazeb14.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION14.512
61755-019-01Inmazeb1 in 1 CARTONINJECTION, SOLUTION112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61755-019INMAZEB (ATOLTIVIMAB, MAFTIVIMAB, AND ODESIVIMAB-EBGN) INJECTION, SOLUTION [REGENERON PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 2 package rows20250109_0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa.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
InmazebATOLTIVIMAB, MAFTIVIMAB, AND ODESIVIMAB-EBGNRegeneron Pharmaceuticals, Inc.0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa2025-12-15Warnings, Adverse reactionsExact identifier
application number: BLA761169
ndc (product): 61755-019

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761169Inmazebatoltivimab, maftivimab, and odesivimab-ebgn351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2461536atoltivimab-maftivimab-odesivimab-ebgn 241.7 MG / 241.7 MG / 241.7 MG in 14.5 ML InjectionPSN0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa12
2571682atoltivimab-maftivimab-odesivimab-ebgn 483.3 MG / 483.3 MG / 483.3 MG in 14.5 ML InjectionPSN0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa12
2461539Inmazeb 241.7 MG / 241.7 MG / 241.7 MG in 14.5 ML InjectionPSN0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa12
2571685Inmazeb 483.3 MG / 483.3 MG / 483.3 MG in 14.5 ML InjectionPSN0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa12
246153914.5 ML atoltivimab-ebgn 16.7 MG/ML / maftivimab-ebgn 16.7 MG/ML / odesivimab-ebgn 16.7 MG/ML Injection [Inmazeb]SBD0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa12
257168514.5 ML atoltivimab-ebgn 33.3 MG/ML / maftivimab-ebgn 33.3 MG/ML / odesivimab-ebgn 33.3 MG/ML Injection [Inmazeb]SBD0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa12
246153614.5 ML atoltivimab-ebgn 16.7 MG/ML / maftivimab-ebgn 16.7 MG/ML / odesivimab-ebgn 16.7 MG/ML InjectionSCD0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa12
257168214.5 ML atoltivimab-ebgn 33.3 MG/ML / maftivimab-ebgn 33.3 MG/ML / odesivimab-ebgn 33.3 MG/ML InjectionSCD0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa12
2461536atoltivimab-ebgn 16.67 MG/ML / maftivimab-ebgn 16.67 MG/ML / odesivimab-ebgn 16.67 MG/ML per 14.5 ML InjectionSY0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa12
2461536atoltivimab-ebgn 241.7 MG / maftivimab-ebgn 241.7 MG / odesivimab-ebgn 241.7 MG per 14.5 ML InjectionSY0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa12
2571682atoltivimab-ebgn 33.33 MG/ML / maftivimab-ebgn 33.33 MG/ML / odesivimab-ebgn 33.33 MG/ML per 14.5 ML InjectionSY0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa12
2571682atoltivimab-ebgn 483.3 MG / maftivimab-ebgn 483.3 MG / odesivimab-ebgn 483.3 MG per 14.5 ML InjectionSY0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa12
2461536atoltivimab-maftivimab-odesivimab-ebgn 241.7 MG / 241.7 MG / 241.7 MG per 14.5 ML InjectionSY0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa12
2571682atoltivimab-maftivimab-odesivimab-ebgn 483.3 MG / 483.3 MG / 483.3 MG per 14.5 ML InjectionSY0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa12
2461539Inmazeb (atoltivimab-ebgn 16.67 MG/ML / maftivimab-ebgn 16.67 MG/ML / odesivimab-ebgn 16.67 MG/ML) per 14.5 ML InjectionSY0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa12
2461539Inmazeb (atoltivimab-ebgn 241.7 MG / maftivimab-ebgn 241.7 MG / odesivimab-ebgn 241.7 MG) per 14.5 ML InjectionSY0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa12
2571685Inmazeb (atoltivimab-ebgn 33.33 MG/ML / maftivimab-ebgn 33.33 MG/ML / odesivimab-ebgn 33.33 MG/ML) per 14.5 ML InjectionSY0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa12
2571685Inmazeb (atoltivimab-ebgn 483.3 MG / maftivimab-ebgn 483.3 MG / odesivimab-ebgn 483.3 MG) per 14.5 ML InjectionSY0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa12
2461539Inmazeb 241.7 MG / 241.7 MG / 241.7 MG per 14.5 ML InjectionSY0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa12
2571685Inmazeb 483.3 MG / 483.3 MG / 483.3 MG per 14.5 ML InjectionSY0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61755-019-006175500190014.5 mL in 1 VIAL, SINGLE-DOSE14.5 mlHistorical
61755-019-01617550019011 VIAL, SINGLE-DOSE in 1 CARTON (61755-019-01) / 14.5 mL in 1 VIAL, SINGLE-DOSE (61755-019-00) 2021-07-290000-00-00NoNoCurrent