NDC 0245-0871

Vogelxo

Testosterone

Vogelxo is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Upsher-smith Laboratories, Llc. The primary component is Testosterone.

• Product ID: 0245-0871_507bfcdb-4b79-4ee4-981a-bba69cbe0028
• NDC: 0245-0871
• Product Type: Human Prescription Drug
• Proprietary Name: Vogelxo
• Generic Name: Testosterone
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2014-06-09
• Marketing Category: NDA / NDA
• Application Number: NDA204399
• Labeler Name: Upsher-Smith Laboratories, LLC
• Substance Name: TESTOSTERONE
• Active Ingredient Strength: 50 mg/5g
• 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 0245-0871-05

30 TUBE in 1 CARTON (0245-0871-05) > 5 g in 1 TUBE (0245-0871-65)

• Marketing Start Date: 2014-06-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0245-0871-05 [00245087105]

Vogelxo GEL

• Marketing Category: NDA
• Application Number: NDA204399
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2014-06-09

NDC 0245-0871-35 [00245087135]

Vogelxo GEL

• Marketing Category: NDA
• Application Number: NDA204399
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2014-06-09

NDC 0245-0871-65 [00245087165]

Vogelxo GEL

• Marketing Category: NDA
• Application Number: NDA204399
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2014-06-09

NDC 0245-0871-89 [00245087189]

Vogelxo GEL

• Marketing Category: NDA
• Application Number: NDA204399
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2014-06-09

Drug Details

Active Ingredients

Ingredient	Strength
TESTOSTERONE	50 mg/5g

OpenFDA Data

• SPL SET ID: 2dd150f6-cdfd-4d51-8888-12b288f26262
• Manufacturer:
  • Upsher-Smith Laboratories, LLC
• UNII:
  • 3XMK78S47O
• RxNorm Concept Unique ID - RxCUI:
  • 1596785
  • 1597134
  • 1596780
  • 1597129

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0245-0871	Vogelxo	Testosterone
0245-0872	Vogelxo	Testosterone
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