NDC 66887-004

Testopel

Testosterone

Testopel is a Subcutaneous Pellet in the Human Prescription Drug category. It is labeled and distributed by Endo Pharmaceuticals, Inc.. The primary component is Testosterone.

• Product ID: 66887-004_0d89d327-599a-47fd-9cec-e9e932bacf98
• NDC: 66887-004
• Product Type: Human Prescription Drug
• Proprietary Name: Testopel
• Generic Name: Testosterone
• Dosage Form: Pellet
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2014-10-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA080911
• Labeler Name: Endo Pharmaceuticals, Inc.
• Substance Name: TESTOSTERONE
• Active Ingredient Strength: 75 mg/1
• 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 66887-004-10

10 AMPULE in 1 BOX (66887-004-10) > 1 PELLET in 1 AMPULE (66887-004-01)

• Marketing Start Date: 2014-10-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66887-004-01 [66887000401]

Testopel PELLET

• Marketing Category: ANDA
• Application Number: ANDA080911
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-10-31

NDC 66887-004-10 [66887000410]

Testopel PELLET

• Marketing Category: ANDA
• Application Number: ANDA080911
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-10-31

NDC 66887-004-20 [66887000420]

Testopel PELLET

• Marketing Category: ANDA
• Application Number: ANDA080911
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-10-31

Drug Details

Active Ingredients

Ingredient	Strength
TESTOSTERONE	75 mg/1

OpenFDA Data

• SPL SET ID: 03b9c0b1-5884-11e4-8ed6-0800200c9a66
• Manufacturer:
  • Endo Pharmaceuticals, Inc.
• UNII:
  • 3XMK78S47O
• RxNorm Concept Unique ID - RxCUI:
  • 318240
  • 404405

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
43773-1001	Testopel	Testopel
66887-004	Testopel	Testopel
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