NDC 52609-0001

ALKERAN

Melphalan

ALKERAN is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Apopharma Usa, Inc.. The primary component is Melphalan.

• Product ID: 52609-0001_b8048e20-e808-34c5-f821-de0b006fa278
• NDC: 52609-0001
• Product Type: Human Prescription Drug
• Proprietary Name: ALKERAN
• Generic Name: Melphalan
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2011-01-01
• Marketing Category: NDA / NDA
• Application Number: NDA014691
• Labeler Name: ApoPharma USA, Inc.
• Substance Name: MELPHALAN
• Active Ingredient Strength: 2 mg/1
• Pharm Classes: Alkylating Activity [MoA],Alkylating Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 52609-0001-5

50 TABLET, FILM COATED in 1 BOTTLE (52609-0001-5)

• Marketing Start Date: 2011-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52609-0001-5 [52609000105]

ALKERAN TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA014691
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-01-01

Drug Details

Active Ingredients

Ingredient	Strength
MELPHALAN	2 mg/1

OpenFDA Data

• SPL SET ID: ff913271-0090-4832-a0fe-5154fe8f97b9
• Manufacturer:
  • ApoPharma USA, Inc.
• UNII:
  • Q41OR9510P
• RxNorm Concept Unique ID - RxCUI:
  • 197919
  • 105562

Pharmacological Class

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

Medicade Reported Pricing

52609000105 ALKERAN 2 MG TABLET

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
52609-0001	ALKERAN	melphalan
52609-3001	ALKERAN	melphalan hydrochloride
68152-109	EVOMELA	Melphalan
69605-001	EVOMELA	Melphalan
72893-001	EVOMELA	Melphalan