NDC 0115-1408

MethylTESTOSTERone

Methyltestosterone

MethylTESTOSTERone is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Impax Generics. The primary component is Methyltestosterone.

• Product ID: 0115-1408_12e53866-d06b-474a-809e-04b61cc08d02
• NDC: 0115-1408
• Product Type: Human Prescription Drug
• Proprietary Name: MethylTESTOSTERone
• Generic Name: Methyltestosterone
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2015-09-21
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204851
• Labeler Name: Impax Generics
• Substance Name: METHYLTESTOSTERONE
• Active Ingredient Strength: 10 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 0115-1408-01

100 CAPSULE in 1 BOTTLE (0115-1408-01)

• Marketing Start Date: 2015-09-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0115-1408-08 [00115140808]

MethylTESTOSTERone CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA204851
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-09-21

NDC 0115-1408-01 [00115140801]

MethylTESTOSTERone CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA204851
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-09-21

NDC 0115-1408-03 [00115140803]

MethylTESTOSTERone CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA204851
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-09-21

Drug Details

Active Ingredients

Ingredient	Strength
METHYLTESTOSTERONE	10 mg/1

OpenFDA Data

• SPL SET ID: 9bed4886-fcd0-4056-be8d-5bb4d15081ce
• Manufacturer:
  • Impax Generics
• UNII:
  • V9EFU16ZIF
• RxNorm Concept Unique ID - RxCUI:
  • 197975
• UPC Code:
  • 0301151408012

Pharmacological Class

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

NDC Crossover Matching brand name "MethylTESTOSTERone" or generic name "Methyltestosterone"

NDC	Brand Name	Generic Name
0115-1408	MethylTESTOSTERone	METHYLTESTOSTERONE
70954-255	Methyltestosterone	Methyltestosterone
0115-7037	METHITEST	METHYLTESTOSTERONE