FDA.reportPublic FDA data

IMJUDO

Product NDC
0310-4535
11-digit product format
003104535
Labeler code
0310
Product ID
0310-4535_390ff583-8e40-4690-ac4c-b4eaef2229d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tremelimumab
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
AstraZeneca Pharmaceuticals LP
Application
BLA761289
Marketing category
BLA
Marketing start
2022-10-21
Substance
TREMELIMUMAB
Active strength
300 mg/15mL
Pharmacologic classes
CTLA-4-directed Antibody Interactions [MoA], CTLA-4-directed Blocking Antibody [EPC], Increased T Lymphocyte Activation [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TREMELIMUMAB300 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QEN1X95CIXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2619317Internal RxNorm lookup
2619323Internal RxNorm lookup
2619325Internal RxNorm lookup
2619326Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6690679c-be2f-4588-a2e4-89fff74dd6beAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f5a86778-47f0-4a54-9482-cbf1549c28a6Product name120231024
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0310-4535-30IMJUDO1 in 1 CARTONINJECTION, SOLUTION114
0310-4535-30IMJUDO15 mL in 1 VIALINJECTION, SOLUTION1514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-4535-30ML - Milliliter0310-4535f44fb4fc-733f-44eb-bc4d-61be1236129212022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-4535IMJUDO (TREMELIMUMAB) INJECTION, SOLUTION [ASTRAZENECA PHARMACEUTICALS LP]11Current NDC, Legacy NDC, 2 package rows20240802_6690679c-be2f-4588-a2e4-89fff74dd6be.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
IMJUDOTREMELIMUMABAstraZeneca Pharmaceuticals LP6690679c-be2f-4588-a2e4-89fff74dd6be2024-07-24Warnings, Adverse reactionsExact identifier
application number: BLA761289
ndc (product): 0310-4535

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761289Imjudotremelimumab-actl351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2619326IMJUDO 25 MG in 1.25 ML InjectionPSN6690679c-be2f-4588-a2e4-89fff74dd6be14
2619323IMJUDO 300 MG in 15 ML InjectionPSN6690679c-be2f-4588-a2e4-89fff74dd6be14
2619325tremelimumab-actl 25 MG in 1.25 ML InjectionPSN6690679c-be2f-4588-a2e4-89fff74dd6be14
2619317tremelimumab-actl 300 MG in 15 ML InjectionPSN6690679c-be2f-4588-a2e4-89fff74dd6be14
26193261.25 ML tremelimumab-actl 20 MG/ML Injection [Imjudo]SBD6690679c-be2f-4588-a2e4-89fff74dd6be14
261932315 ML tremelimumab-actl 20 MG/ML Injection [Imjudo]SBD6690679c-be2f-4588-a2e4-89fff74dd6be14
26193251.25 ML tremelimumab-actl 20 MG/ML InjectionSCD6690679c-be2f-4588-a2e4-89fff74dd6be14
261931715 ML tremelimumab-actl 20 MG/ML InjectionSCD6690679c-be2f-4588-a2e4-89fff74dd6be14
2619326Imjudo 20 MG/ML per 1.25 ML InjectionSY6690679c-be2f-4588-a2e4-89fff74dd6be14
2619323Imjudo 20 MG/ML per 15 ML InjectionSY6690679c-be2f-4588-a2e4-89fff74dd6be14
2619326Imjudo 25 MG per 1.25 ML InjectionSY6690679c-be2f-4588-a2e4-89fff74dd6be14
2619323Imjudo 300 MG per 15 ML InjectionSY6690679c-be2f-4588-a2e4-89fff74dd6be14
2619325tremelimumab-actl 20 MG/ML per 1.25 ML InjectionSY6690679c-be2f-4588-a2e4-89fff74dd6be14
2619317tremelimumab-actl 20 MG/ML per 15 ML InjectionSY6690679c-be2f-4588-a2e4-89fff74dd6be14
2619325tremelimumab-actl 25 MG per 1.25 ML InjectionSY6690679c-be2f-4588-a2e4-89fff74dd6be14
2619317tremelimumab-actl 300 MG per 15 ML InjectionSY6690679c-be2f-4588-a2e4-89fff74dd6be14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0310-4535-30003104535301 VIAL in 1 CARTON (0310-4535-30) / 15 mL in 1 VIAL1 vial2022-10-210000-00-00NoNoCurrent