0310-4535 NDC - IMJUDO (TREMELIMUMAB)

Drug Information

  • Product NDC: 0310-4535
  • Proprietary Name: IMJUDO
  • Non Proprietary Name: tremelimumab
  • Active Ingredient(s): 300 mg/15mL TREMELIMUMAB
  • Administration Route(s): INTRAVENOUS
  • Dosage Form(s): INJECTION, SOLUTION
  • Pharmacy Class(es): CTLA-4-directed Antibody Interactions [MoA]; CTLA-4-directed Blocking Antibody [EPC]; Increased T Lymphocyte Activation [PE]

Labeler Information

Field Name Field Value
Labeler Name: AstraZeneca Pharmaceuticals LP
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: BLA761289
Marketing Category: BLA
Start Marketing Date:10/21/2022

Package Information

No. Package Code Package Description Billing Unit
10310-4535-301 VIAL in 1 CARTON (0310-4535-30) / 15 mL in 1 VIALML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0310-4535The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEIMJUDOThis is the date that the labeler indicates was the start of its marketing of the drug product.
NON PROPRIETARY NAMEtremelimumabThis is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
DOSAGE FORM NAMEINJECTION, SOLUTIONProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
ROUTE NAMEINTRAVENOUSThis corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
START MARKETING DATE10/21/2022Name of Company corresponding to the labeler code segment of the Product NDC.
MARKETING CATEGORY NAMEBLAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERBLA761289This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEAstraZeneca Pharmaceuticals LPName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMETREMELIMUMABAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH300 
ACTIVE INGRED UNITmg/15mL 
PHARM CLASSESCTLA-4-directed Antibody Interactions [MoA], CTLA-4-directed Blocking Antibody [EPC], Increased T Lymphocyte Activation [PE] 

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This page was last updated on: 12/6/2025

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