NDC 0051-8462

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: 0051-8462_1622cf7d-0e00-87a3-d58e-cd3f7730e76e
• NDC: 0051-8462
• 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: AbbVie Inc.
• 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: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0051-8462-30

30 PACKET in 1 CARTON (0051-8462-30) > 2.5 g in 1 PACKET (0051-8462-01)

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

NDC SPL Data Element Entries

NDC 0051-8462-30 [00051846230]

Androgel GEL

• Marketing Category: NDA
• Application Number: NDA022309
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2011-04-29

NDC 0051-8462-12 [00051846212]

Androgel GEL

• Marketing Category: NDA
• Application Number: NDA022309
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2012-09-19

NDC 0051-8462-01 [00051846201]

Androgel GEL

• Marketing Category: NDA
• Application Number: NDA022309
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2012-09-19

NDC 0051-8462-33 [00051846233]

Androgel GEL

• Marketing Category: NDA
• Application Number: NDA022309
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2011-04-29

NDC 0051-8462-31 [00051846231]

Androgel GEL

• Marketing Category: NDA
• Application Number: NDA022309
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2011-04-29

NDC 0051-8462-02 [00051846202]

Androgel GEL

• Marketing Category: NDA
• Application Number: NDA022309
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-04-29
• Marketing End Date: 2012-09-19

Drug Details

Active Ingredients

Ingredient	Strength
TESTOSTERONE	16.2 mg/g

OpenFDA Data

• SPL SET ID: 8677ba5b-8374-46cb-854c-403972e9ddf3
• Manufacturer:
  • AbbVie Inc.
• UNII:
  • 3XMK78S47O
• RxNorm Concept Unique ID - RxCUI:
  • 1597127
  • 1597126
  • 1597075
  • 1597076
  • 1597120
  • 1597121
• UPC Code:
  • 0300518462339
  • 0300518462315

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