Drug Information

Product NDC: 0002-1975

Proprietary Name: AXIRON

Non Proprietary Name: testosterone

Active Ingredient(s):
  • 30 mg/1.5mL TESTOSTERONE

Administration Route(s): TOPICAL

Dosage Form(s): SOLUTION

Pharmacy Class(es):
  • Androgen [EPC];
  • Androgen Receptor Agonists [MoA];
  • Androstanes [Chemical/Ingredient]

Labeler Information

Labeler Name: Eli Lilly and Company
FDA Application Number: NDA022504
Marketing Category: NDA
Start Marketing Date:12/1/2010
DEA Schedule:CIII

Package Information

No. Package Code Package Description
1 0002-1975-61 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0002-1975-61) > 90 mL in 1 BOTTLE, WITH APPLICATOR
2 0002-1975-90 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0002-1975-90) > 90 mL in 1 BOTTLE, WITH APPLICATOR

NDC Record

No. Field Name Field Value Field Definition
1 PRODUCT NDC 0002-1975 The 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.
2 PRODUCT TYPE NAME HUMAN PRESCRIPTION DRUG Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
3 PROPRIETARY NAME AXIRON Also known as the trade name. It is the name of the product chosen by the labeler.
4 NON PROPRIETARY NAME testosterone Sometimes called the generic name, this is usually the active ingredient(s) of the product.
5 DOSAGE FORM NAME SOLUTION The translation of the DosageForm Code submitted by the firm.
6 ROUTE NAME TOPICAL The translation of the Route Code submitted by the firm, indicating route of administration.
7 START MARKETING DATE 12/1/2010 This is the date that the labeler indicates was the start of its marketing of the drug product.
8 MARKETING CATEGORY NAME NDA Product 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.
9 APPLICATION NUMBER NDA022504 This 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.
10 LABELER NAME Eli Lilly and Company Name of Company corresponding to the labeler code segment of the Product NDC.
11 SUBSTANCE NAME TESTOSTERONE This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
14 PHARM CLASSES Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient]
15 DEA SCHEDULE CIII This 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: 5/11/2016