NDC 50222-503

Picato

Ingenol Mebutate

Picato is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Leo Pharma Inc.. The primary component is Ingenol Mebutate.

• Product ID: 50222-503_06d68329-9481-4558-a6ed-14a38e52f2a2
• NDC: 50222-503
• Product Type: Human Prescription Drug
• Proprietary Name: Picato
• Generic Name: Ingenol Mebutate
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2012-01-23
• Marketing Category: NDA / NDA
• Application Number: NDA202833
• Labeler Name: LEO Pharma Inc.
• Substance Name: INGENOL MEBUTATE
• Active Ingredient Strength: 500 ug/g
• Pharm Classes: Cell Death Inducer [EPC],Increased Cellular Death [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50222-503-47

2 TUBE in 1 CARTON (50222-503-47) > .47 g in 1 TUBE

• Marketing Start Date: 2012-01-23
• Marketing End Date: 2022-04-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50222-503-92 [50222050392]

Picato GEL

• Marketing Category: NDA
• Application Number: NDA202833
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-01-23

NDC 50222-503-47 [50222050347]

Picato GEL

• Marketing Category: NDA
• Application Number: NDA202833
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-01-23

Drug Details

Active Ingredients

Ingredient	Strength
INGENOL MEBUTATE	500 ug/g

OpenFDA Data

• SPL SET ID: 5accc7a5-8209-4680-b0ae-2a6963500419
• Manufacturer:
  • LEO Pharma Inc.
• UNII:
  • 7686S50JAH
• RxNorm Concept Unique ID - RxCUI:
  • 1242815
  • 1242817
  • 1242819
  • 1242810

Pharmacological Class

• Cell Death Inducer [EPC]
• Increased Cellular Death [PE]

Medicade Reported Pricing

50222050347 PICATO 0.05% GEL

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Picato" or generic name "Ingenol Mebutate"

NDC	Brand Name	Generic Name
50222-502	Picato	ingenol mebutate
50222-503	Picato	ingenol mebutate