Drug Information

  • Product NDC: 0002-6885
  • Proprietary Name: Baricitinib
  • Non Proprietary Name: baricitinib
  • Active Ingredient(s): 4 mg/1 BARICITINIB
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET, FILM COATED
  • Pharmacy Class(es): Janus Kinase Inhibitor [EPC]; Janus Kinase Inhibitors [MoA]/li>

Labeler Information

Field Name Field Value
Labeler Name: Eli Lilly and Company
FDA Application Number:
Start Marketing Date:12/20/2021

Package Information

No. Package Code Package Description Billing Unit
10002-6885-3030 TABLET, FILM COATED in 1 BOTTLE (0002-6885-30)

NDC Record

Field Name Field Value Definition
PRODUCT NDC0002-6885The 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 NAMEBaricitinibThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEbaricitinibThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, FILM COATEDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE12/20/2021This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEEMERGENCY USE AUTHORIZATIONProduct 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.
LABELER NAMEEli Lilly and CompanyName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEBARICITINIBAn 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.
PHARM CLASSESJanus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA] 

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This page was last updated on: 4/12/2024