NDC 25010-305

Demser

Metyrosine

Demser is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Americas Inc.. The primary component is Metyrosine.

• Product ID: 25010-305_20af3c40-a18c-431e-8aa7-5a62e81f50f7
• NDC: 25010-305
• Product Type: Human Prescription Drug
• Proprietary Name: Demser
• Generic Name: Metyrosine
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 1979-10-03
• Marketing Category: NDA / NDA
• Application Number: NDA017871
• Labeler Name: Bausch Health Americas Inc.
• Substance Name: METYROSINE
• Active Ingredient Strength: 250 mg/1
• Pharm Classes: Catecholamine Synthesis Inhibitor [EPC],Catecholamine Synthesis Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 25010-305-15

100 CAPSULE in 1 BOTTLE (25010-305-15)

• Marketing Start Date: 1979-10-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 25010-305-15 [25010030515]

Demser CAPSULE

• Marketing Category: NDA
• Application Number: NDA017871
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1979-10-03

Drug Details

Active Ingredients

Ingredient	Strength
METYROSINE	250 mg/1

OpenFDA Data

• SPL SET ID: 32fb2f2f-34b5-4cd5-9145-c3ab37c5ca92
• Manufacturer:
  • Aton Pharma, Inc.
• UNII:
  • DOQ0J0TPF7
• RxNorm Concept Unique ID - RxCUI:
  • 201388
  • 197980

Pharmacological Class

• Catecholamine Synthesis Inhibitor [EPC]
• Catecholamine Synthesis Inhibitors [MoA]

NDC Crossover Matching brand name "Demser" or generic name "Metyrosine"

NDC	Brand Name	Generic Name
25010-305	Demser	metyrosine
60219-1621	metyrosine	metyrosine
68682-310	Metyrosine	Metyrosine
69238-1621	metyrosine	metyrosine