Drug Information

Product NDC: 0009-5036

Proprietary Name:

Non Proprietary Name: Testosterone Undecanoate

Active Ingredient(s):

Administration Route(s):

Dosage Form(s): POWDER

Labeler Information

Labeler Name: Pharmacia and Upjohn Company LLC
FDA Application Number:
Marketing Category: BULK INGREDIENT
Start Marketing Date:3/14/2014
DEA Schedule:CIII

Package Information

No. Package Code Package Description Billing Unit
10009-5036-011 BAG in 1 DRUM (0009-5036-01) / 50 kg in 1 BAG

NDC Record

Field Name Field Value Definition
PRODUCT NDC0009-5036The 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 NAMEBULK INGREDIENTIndicates 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.
NON PROPRIETARY NAMETestosterone UndecanoateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEPOWDERThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE3/14/2014This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEBULK INGREDIENTProduct 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 NAMEPharmacia and Upjohn Company LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMETESTOSTERONE UNDECANOATEAn 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.
DEA SCHEDULECIIIThis is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

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This page was last updated on: 5/24/2024