NDC 0832-0086

Androxy

Fluoxymesterone

Androxy is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Upsher-smith Laboratories, Llc. The primary component is Fluoxymesterone.

• Product ID: 0832-0086_c3b32092-fa7d-421c-85ea-03e2b79269a9
• NDC: 0832-0086
• Product Type: Human Prescription Drug
• Proprietary Name: Androxy
• Generic Name: Fluoxymesterone
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 1983-10-21
• Marketing Category: ANDA / ANDA
• Application Number: ANDA088342
• Labeler Name: Upsher-Smith Laboratories, LLC
• Substance Name: FLUOXYMESTERONE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0832-0086-00

100 TABLET in 1 BOTTLE (0832-0086-00)

• Marketing Start Date: 1983-10-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0832-0086-00 [00832008600]

Androxy TABLET

• Marketing Category: ANDA
• Application Number: ANDA088342
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1983-10-21

Drug Details

Active Ingredients

Ingredient	Strength
FLUOXYMESTERONE	10 mg/1

OpenFDA Data

• SPL SET ID: 5328c194-5650-4d1f-9e28-8cea038cce81
• Manufacturer:
  • Upsher-Smith Laboratories, LLC
• UNII:
  • 9JU12S4YFY
• RxNorm Concept Unique ID - RxCUI:
  • 197710
  • 692688

Pharmacological Class

• Androgen [EPC]
• Androgen Receptor Agonists [MoA]
• Androstanes [CS]
• Androgen [EPC]
• Androgen Receptor Agonists [MoA]
• Androstanes [CS]