NDC 69654-239

Natesto

Testosterone

Natesto is a Nasal Gel in the Human Prescription Drug category. It is labeled and distributed by Aytu Bioscience, Inc.. The primary component is Testosterone.

• Product ID: 69654-239_23a44b91-1f72-4304-89e3-d68626736fae
• NDC: 69654-239
• Product Type: Human Prescription Drug
• Proprietary Name: Natesto
• Generic Name: Testosterone
• Dosage Form: Gel
• Route of Administration: NASAL
• Marketing Start Date: 2017-09-01
• Marketing Category: NDA / NDA
• Application Number: NDA205488
• Labeler Name: Aytu BioScience, Inc.
• Substance Name: TESTOSTERONE
• Active Ingredient Strength: 6 mg/1
• Pharm Classes: Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 69654-239-01

1 BOTTLE, PUMP in 1 CARTON (69654-239-01) > 60 GEL in 1 BOTTLE, PUMP

• Marketing Start Date: 2017-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69654-239-01 [69654023901]

Natesto GEL

• Marketing Category: NDA
• Application Number: NDA205488
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2017-09-01

Drug Details

Active Ingredients

Ingredient	Strength
TESTOSTERONE	5.5 mg/1

OpenFDA Data

• SPL SET ID: 68d0447b-f75a-4fb2-96ba-de822b74aebb
• Manufacturer:
  • Aytu BioScience, Inc.
• UNII:
  • 3XMK78S47O
• RxNorm Concept Unique ID - RxCUI:
  • 1596784
  • 1596782
• UPC Code:
  • 0369654239014

Pharmacological Class

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

Medicade Reported Pricing

69654023901 NATESTO NASAL 5.5 MG/0.122 GM

Pricing Unit: GM | Drug Type:

NDC Crossover Matching brand name "Natesto" or generic name "Testosterone"

NDC	Brand Name	Generic Name
69654-239	Natesto	Natesto
0023-5990	Androderm	Testosterone
0023-5992	Androderm	Testosterone
0051-8425	Androgel	Testosterone
0051-8450	Androgel	Testosterone
0051-8462	Androgel	Testosterone
0254-1012	Testosterone	testosterone
0591-2114	Testosterone	Testosterone
0591-2363	Testosterone	testosterone
0591-2921	Testosterone	Testosterone
0591-2924	Testosterone	Testosterone
0591-2925	Testosterone	Testosterone
0591-2926	Testosterone	Testosterone
0591-3216	Testosterone	Testosterone
0245-0871	Vogelxo	Testosterone
0245-0872	Vogelxo	Testosterone