NDC 73372-0116

SCENESSE

Afamelanotide

SCENESSE is a Subcutaneous Implant in the Human Prescription Drug category. It is labeled and distributed by Clinuvel Inc.. The primary component is Afamelanotide.

• Product ID: 73372-0116_94f53286-11de-7fbb-e053-2a95a90a7c48
• NDC: 73372-0116
• Product Type: Human Prescription Drug
• Proprietary Name: SCENESSE
• Generic Name: Afamelanotide
• Dosage Form: Implant
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2019-12-31
• Marketing Category: NDA / NDA
• Application Number: NDA210797
• Labeler Name: CLINUVEL INC.
• Substance Name: AFAMELANOTIDE
• Active Ingredient Strength: 16 mg/16mg
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 73372-0116-1

1 VIAL, GLASS in 1 CARTON (73372-0116-1) > 1 mg in 1 VIAL, GLASS

• Marketing Start Date: 2019-12-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 73372-0116-1 [73372011601]

SCENESSE IMPLANT

• Marketing Category: NDA
• Application Number: NDA210797
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-12-31

Drug Details

Active Ingredients

Ingredient	Strength
AFAMELANOTIDE	16 mg/16mg

OpenFDA Data

• SPL SET ID: 94f53286-11dd-7fbb-e053-2a95a90a7c48
• Manufacturer:
  • CLINUVEL INC.
• UNII:
  • QW68W3J66U
• RxNorm Concept Unique ID - RxCUI:
  • 2262259
  • 2262254
• UPC Code:
  • 0373372011616

NDC Crossover Matching brand name "SCENESSE" or generic name "Afamelanotide"

NDC	Brand Name	Generic Name
73372-0116	SCENESSE	afamelanotide
73850-0116	SCENESSE	Afamelanotide