NDC 50090-1306

Androgel

Testosterone

Androgel is a Transdermal Gel in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions Llc. The primary component is Testosterone.

• Product ID: 50090-1306_295e436d-26f7-410f-a93a-5b660fc216c4
• NDC: 50090-1306
• Product Type: Human Prescription Drug
• Proprietary Name: Androgel
• Generic Name: Testosterone
• Dosage Form: Gel
• Route of Administration: TRANSDERMAL
• Marketing Start Date: 2011-04-29
• Marketing Category: NDA / NDA
• Application Number: NDA022309
• Labeler Name: A-S Medication Solutions LLC
• Substance Name: TESTOSTERONE
• Active Ingredient Strength: 16 mg/g
• Pharm Classes: Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
• DEA Schedule: CIII
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 50090-1306-0

1 BOTTLE, PUMP in 1 CARTON (50090-1306-0) > 75 g in 1 BOTTLE, PUMP

• Marketing Start Date: 2011-04-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-1306-0 [50090130600]

Androgel GEL

• Marketing Category: NDA
• Application Number: NDA022309
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-04-29
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
TESTOSTERONE	16.2 mg/g

OpenFDA Data

• SPL SET ID: a8253ce7-77df-49d4-8077-816cf4dc234f
• Manufacturer:
  • A-S Medication Solutions LLC
• UNII:
  • 3XMK78S47O

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0051-8425	Androgel	Testosterone
0051-8450	Androgel	Testosterone
0051-8462	Androgel	Testosterone
21695-112	Androgel	Androgel
50090-1306	Androgel	Androgel
0023-5990	Androderm	Testosterone
0023-5992	Androderm	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