NDC 72893-001

EVOMELA

Melphalan

EVOMELA is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Acrotech Biopharma Llc. The primary component is Melphalan Hydrochloride.

• Product ID: 72893-001_17db6f22-230b-400b-beec-21b86ff10cd8
• NDC: 72893-001
• Product Type: Human Prescription Drug
• Proprietary Name: EVOMELA
• Generic Name: Melphalan
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-03-31
• Marketing Category: NDA / NDA
• Application Number: NDA207155
• Labeler Name: Acrotech Biopharma LLC
• Substance Name: MELPHALAN HYDROCHLORIDE
• Active Ingredient Strength: 50 mg/10mL
• Pharm Classes: Alkylating Activity [MoA],Alkylating Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 72893-001-01

1 VIAL in 1 CARTON (72893-001-01) > 20 mL in 1 VIAL

• Marketing Start Date: 2016-03-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72893-001-01 [72893000101]

EVOMELA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA207155
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-03-31

Drug Details

Active Ingredients

Ingredient	Strength
MELPHALAN HYDROCHLORIDE	50 mg/10mL

OpenFDA Data

• SPL SET ID: 69f55869-dc11-408e-8fc7-47634269a52c
• Manufacturer:
  • Acrotech Biopharma LLC
• UNII:
  • 1VXP4V453T
• RxNorm Concept Unique ID - RxCUI:
  • 1745090
  • 311487

Pharmacological Class

• Alkylating Activity [MoA]
• Alkylating Drug [EPC]

NDC Crossover Matching brand name "EVOMELA" or generic name "Melphalan"

NDC	Brand Name	Generic Name
68152-109	EVOMELA	Melphalan
69605-001	EVOMELA	Melphalan
72893-001	EVOMELA	Melphalan
52609-0001	ALKERAN	melphalan