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 Identifiers#

Field, Values table
FieldValues
UniiQEN1X95CIX
Rxcui2619317, 2619323, 2619325, 2619326

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

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