NDC 0015-3080

LYSODREN

Mitotane

LYSODREN is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by E.r. Squibb & Sons, L.l.c.. The primary component is Mitotane.

• Product ID: 0015-3080_bacf9c5c-6119-4219-8d8d-f3c2db33e18e
• NDC: 0015-3080
• Product Type: Human Prescription Drug
• Proprietary Name: LYSODREN
• Generic Name: Mitotane
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2009-06-01
• Marketing End Date: 2021-03-31
• Marketing Category: NDA / NDA
• Application Number: NDA016885
• Labeler Name: E.R. Squibb & Sons, L.L.C.
• Substance Name: MITOTANE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Cytochrome P450 3A4 Inducers [MoA]
• NDC Exclude Flag: N

Packaging

NDC 0015-3080-60

100 TABLET in 1 BOTTLE (0015-3080-60)

• Marketing Start Date: 2009-06-01
• Marketing End Date: 2021-03-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0015-3080-60 [00015308060]

LYSODREN TABLET

• Marketing Category: NDA
• Application Number: NDA016885
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-06-01
• Marketing End Date: 2021-03-31

Drug Details

Active Ingredients

Ingredient	Strength
MITOTANE	500 mg/1

OpenFDA Data

• SPL SET ID: e9fba7d4-a0ec-4bfa-9b5b-ec97a9710fd3
• Manufacturer:
  • E.R. Squibb & Sons, L.L.C.
• UNII:
  • 78E4J5IB5J
• RxNorm Concept Unique ID - RxCUI:
  • 207373
  • 197988
• UPC Code:
  • 0300000000001

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