NDC 63481-183

FORTESTA

Testosterone

FORTESTA is a Topical Gel, Metered in the Human Prescription Drug category. It is labeled and distributed by Endo Pharmaceuticals, Inc.. The primary component is Testosterone.

• Product ID: 63481-183_2dd76747-a4d1-4184-8b61-8ce7e9f58920
• NDC: 63481-183
• Product Type: Human Prescription Drug
• Proprietary Name: FORTESTA
• Generic Name: Testosterone
• Dosage Form: Gel, Metered
• Route of Administration: TOPICAL
• Marketing Start Date: 2010-12-29
• Marketing Category: NDA / NDA
• Application Number: NDA021463
• Labeler Name: Endo Pharmaceuticals, Inc.
• Substance Name: TESTOSTERONE
• Active Ingredient Strength: 10 mg/.5g
• 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 63481-183-16

1 CANISTER in 1 CARTON (63481-183-16) > 60 g in 1 CANISTER

• Marketing Start Date: 2010-12-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63481-183-16 [63481018316]

FORTESTA GEL, METERED

• Marketing Category: NDA
• Application Number: NDA021463
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2010-12-29

NDC 63481-183-18 [63481018318]

FORTESTA GEL, METERED

• Marketing Category: NDA
• Application Number: NDA021463
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-12-29

NDC 63481-183-17 [63481018317]

FORTESTA GEL, METERED

• Marketing Category: NDA
• Application Number: NDA021463
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-12-29

Drug Details

Active Ingredients

Ingredient	Strength
TESTOSTERONE	10 mg/.5g

OpenFDA Data

• SPL SET ID: 053a7300-0bce-11e0-9d16-0002a5d5c51b
• Manufacturer:
  • Endo Pharmaceuticals, Inc.
• UNII:
  • 3XMK78S47O
• RxNorm Concept Unique ID - RxCUI:
  • 1596781
  • 1596783

Pharmacological Class

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

Medicade Reported Pricing

63481018316 FORTESTA 10 MG GEL PUMP

Pricing Unit: GM | Drug Type:

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

NDC	Brand Name	Generic Name
63481-183	FORTESTA	FORTESTA
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