NDC 68152-109

EVOMELA

Melphalan

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

• Product ID: 68152-109_a2bff599-74e3-4d75-8978-38c2d51945e4
• NDC: 68152-109
• 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: Spectrum Pharmaceuticals, Inc.
• 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 68152-109-00

1 VIAL in 1 CARTON (68152-109-00) > 20 mL in 1 VIAL

• Marketing Start Date: 2016-03-31
• Marketing End Date: 2022-03-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68152-109-00 [68152010900]

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: c5d68b96-14bd-4605-b6d2-2bf8b0c5ca8a
• Manufacturer:
  • Spectrum Pharmaceuticals, Inc.
• UNII:
  • 1VXP4V453T
• RxNorm Concept Unique ID - RxCUI:
  • 1745090
  • 311487

Pharmacological Class

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