NDC 73850-0116

SCENESSE

Afamelanotide

SCENESSE is a Subcutaneous Implant in the Human Prescription Drug category. It is labeled and distributed by Csm Clinical Supplies Management Europe Gmbh. The primary component is Afamelanotide.

• Product ID: 73850-0116_a1533405-cdcb-5ece-e053-2a95a90a90c5
• NDC: 73850-0116
• Product Type: Human Prescription Drug
• Proprietary Name: SCENESSE
• Generic Name: Afamelanotide
• Dosage Form: Implant
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2019-02-21
• Marketing End Date: 2020-12-30
• Marketing Category: UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE / UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
• Labeler Name: CSM Clinical Supplies Management Europe GmbH
• Substance Name: AFAMELANOTIDE
• Active Ingredient Strength: 16 mg/16mg
• NDC Exclude Flag: N

Packaging

NDC 73850-0116-1

1 VIAL, GLASS in 1 POUCH (73850-0116-1) > 1 mg in 1 VIAL, GLASS

• Marketing Start Date: 2020-02-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 73850-0116-1 [73850011601]

SCENESSE IMPLANT

• Marketing Category: Unapproved drug for use in drug shor
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-02-21
• Marketing End Date: 2020-12-30

Drug Details

Active Ingredients

Ingredient	Strength
AFAMELANOTIDE	16 mg/16mg

OpenFDA Data

• SPL SET ID: a1533405-cdca-5ece-e053-2a95a90a90c5
• Manufacturer:
  • CSM Clinical Supplies Management Europe GmbH
• UNII:
  • QW68W3J66U
• RxNorm Concept Unique ID - RxCUI:
  • 2262259
  • 2262254

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

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