0002-1975 NDC - AXIRON (TESTOSTERONE)

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
Product Type: HUMAN PRESCRIPTION DRUG
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
1 PRODUCT NDC 0002-1975
2 PRODUCT TYPE NAME HUMAN PRESCRIPTION DRUG
3 PROPRIETARY NAME AXIRON
4 NON PROPRIETARY NAME testosterone
5 DOSAGE FORM NAME SOLUTION
6 ROUTE NAME TOPICAL
7 START MARKETING DATE 12/1/2010
8 MARKETING CATEGORY NAME NDA
9 APPLICATION NUMBER NDA022504
10 LABELER NAME Eli Lilly and Company
11 SUBSTANCE NAME TESTOSTERONE
12 ACTIVE NUMERATOR STRENGTH 30
13 ACTIVE INGRED UNIT mg/1.5mL
14 PHARM CLASSES Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient]
15 DEA SCHEDULE CIII

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This page was last updated on: 11/25/2014