demser

Generic: metyrosine

Labeler: bausch health us, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name demser
Generic Name metyrosine
Labeler bausch health us, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

metyrosine 250 mg/1

Manufacturer
Bausch Health US, LLC

Identifiers & Regulatory

Product NDC 25010-305
Product ID 25010-305_7997d826-eb49-4688-9833-e668985c1e74
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017871
Listing Expiration 2026-12-31
Marketing Start 1979-10-03

Pharmacologic Class

Established (EPC)
catecholamine synthesis inhibitor [epc]
Mechanism of Action
catecholamine synthesis inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25010305
Hyphenated Format 25010-305

Supplemental Identifiers

RxCUI
197980 201388
UNII
DOQ0J0TPF7
NUI
N0000175569 N0000175361

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name demser (source: ndc)
Generic Name metyrosine (source: ndc)
Application Number NDA017871 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (25010-305-15)
source: ndc

Packages (1)

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

Ingredients (1)

metyrosine (250 mg/1)

Linked Drug Pages (1)

Demser ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7997d826-eb49-4688-9833-e668985c1e74", "openfda": {"nui": ["N0000175569", "N0000175361"], "unii": ["DOQ0J0TPF7"], "rxcui": ["197980", "201388"], "spl_set_id": ["32fb2f2f-34b5-4cd5-9145-c3ab37c5ca92"], "pharm_class_epc": ["Catecholamine Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Catecholamine Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Bausch Health US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (25010-305-15)", "package_ndc": "25010-305-15", "marketing_start_date": "19791003"}], "brand_name": "Demser", "product_id": "25010-305_7997d826-eb49-4688-9833-e668985c1e74", "dosage_form": "CAPSULE", "pharm_class": ["Catecholamine Synthesis Inhibitor [EPC]", "Catecholamine Synthesis Inhibitors [MoA]"], "product_ndc": "25010-305", "generic_name": "metyrosine", "labeler_name": "Bausch Health US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Demser", "active_ingredients": [{"name": "METYROSINE", "strength": "250 mg/1"}], "application_number": "NDA017871", "marketing_category": "NDA", "marketing_start_date": "19791003", "listing_expiration_date": "20261231"}