0078-0331 NDC - SIMULECT (BASILIXIMAB)

Drug Information

Product NDC: 0078-0331

Proprietary Name: Simulect

Non Proprietary Name: basiliximab

Active Ingredient(s):
  • 20 mg/5mL BASILIXIMAB


Administration Route(s): INTRAVENOUS

Dosage Form(s): INJECTION, POWDER, FOR SOLUTION

Pharmacy Class(es):
  • Interleukin 2 Receptor Antagonists [MoA];
  • Interleukin 2 Receptor-directed Antibody Interactions [MoA];
  • Interleukin-2 Receptor Blocking Antibody [EPC]

Labeler Information

Labeler Name: Novartis Pharmaceuticals Corporation
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: BLA103764
Marketing Category: BLA
Start Marketing Date:5/12/1998

Package Information

No. Package Code Package Description Billing Unit
10078-0331-841 VIAL, SINGLE-USE in 1 CARTON (0078-0331-84) > 5 mL in 1 VIAL, SINGLE-USEEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0078-0331The 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 NAMESimulectThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEbasiliximabThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, POWDER, FOR SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAVENOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE5/12/1998This is the date that the labeler indicates was the start of its marketing of the drug product.
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 NUMBERBLA103764This 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 NAMENovartis Pharmaceuticals CorporationName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEBASILIXIMABThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH20 
ACTIVE INGRED UNITmg/5mL 
PHARM CLASSESInterleukin 2 Receptor Antagonists [MoA],Interleukin 2 Receptor-directed Antibody Interactions [MoA],Interleukin-2 Receptor Blocking Antibody [EPC] 

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This page was last updated on: 11/18/2019