NDC 0051-8450

Androgel

Testosterone

Androgel is a Transdermal Gel in the Human Prescription Drug category. It is labeled and distributed by Abbvie Inc.. The primary component is Testosterone.

• Product ID: 0051-8450_2e54dd8d-cf81-4c69-ad15-fa24f47dd3da
• NDC: 0051-8450
• Product Type: Human Prescription Drug
• Proprietary Name: Androgel
• Generic Name: Testosterone
• Dosage Form: Gel
• Route of Administration: TRANSDERMAL
• Marketing Start Date: 2011-03-14
• Marketing End Date: 2022-08-31
• Marketing Category: NDA / NDA
• Application Number: NDA021015
• Labeler Name: AbbVie Inc.
• Substance Name: TESTOSTERONE
• Active Ingredient Strength: 10 mg/g
• Pharm Classes: Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
• DEA Schedule: CIII
• NDC Exclude Flag: N

Packaging

NDC 0051-8450-30

30 PACKET in 1 CARTON (0051-8450-30) > 5 g in 1 PACKET (0051-8450-01)

• Marketing Start Date: 2011-03-14
• Marketing End Date: 2022-08-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0051-8450-01 [00051845001]

Androgel GEL

• Marketing Category: NDA
• Application Number: NDA021015
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2011-06-02

NDC 0051-8450-30 [00051845030]

Androgel GEL

• Marketing Category: NDA
• Application Number: NDA021015
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2011-03-14

Drug Details

Active Ingredients

Ingredient	Strength
TESTOSTERONE	10 mg/g

OpenFDA Data

• SPL SET ID: c506aaa3-04f8-4eb1-8dc4-e964cdd08e7f
• Manufacturer:
  • AbbVie Inc.
• UNII:
  • 3XMK78S47O
• RxNorm Concept Unique ID - RxCUI:
  • 1597130
  • 1597074
  • 1597124
  • 1597123
  • 1596780
  • 1597129

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