NDC 76336-080

Lysodren

Mitotane

Lysodren is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Hra Pharma Rare Diseases. The primary component is Mitotane.

• Product ID: 76336-080_73a3f0f8-bc4e-4b27-bcb8-2fb4873652f6
• NDC: 76336-080
• Product Type: Human Prescription Drug
• Proprietary Name: Lysodren
• Generic Name: Mitotane
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2009-01-06
• Marketing Category: NDA / NDA
• Application Number: NDA016885
• Labeler Name: HRA Pharma Rare Diseases
• Substance Name: MITOTANE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Cytochrome P450 3A4 Inducers [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 76336-080-60

1 BOTTLE in 1 CARTON (76336-080-60) > 100 TABLET in 1 BOTTLE

• Marketing Start Date: 2009-01-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 76336-080-60 [76336008060]

Lysodren TABLET

• Marketing Category: NDA
• Application Number: NDA016885
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-01-06

Drug Details

Active Ingredients

Ingredient	Strength
MITOTANE	500 mg/1

OpenFDA Data

• SPL SET ID: f0cd76e9-460c-450e-b094-172e636f340a
• Manufacturer:
  • Laboratoire HRA Pharma
• UNII:
  • 78E4J5IB5J
• RxNorm Concept Unique ID - RxCUI:
  • 207373
  • 197988

Pharmacological Class

• Cytochrome P450 3A4 Inducers [MoA]

NDC Crossover Matching brand name "Lysodren" or generic name "Mitotane"

NDC	Brand Name	Generic Name
0015-3080	LYSODREN	MITOTANE
76336-080	Lysodren	mitotane