Stalevo

Generic: carbidopa, levodopa, and entacapone

Labeler: Almatica Pharma LLC
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive

Drug Facts

Product Profile

Brand Name Stalevo
Generic Name carbidopa, levodopa, and entacapone
Labeler Almatica Pharma LLC
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

CARBIDOPA 18.75 mg/1, ENTACAPONE 200 mg/1, LEVODOPA 75 mg/1

Identifiers & Regulatory

Product NDC 52427-809
Product ID 52427-809_37d4ceb8-10e7-0fa8-7171-077b2cd6affd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021485
Marketing Start 2020-10-05
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52427809
Hyphenated Format 52427-809

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 Stalevo (source: ndc)
Generic Name carbidopa, levodopa, and entacapone (source: ndc)
Application Number NDA021485 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 18.75 mg/1
  • 200 mg/1
  • 75 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (52427-809-01) / 100 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

52427-809-01 1 BOTTLE in 1 CARTON (52427-809-01) / 100 TABLET, FILM COATED in 1 BOTTLE

Ingredients (3)

CARBIDOPA (18.75 mg/1) ENTACAPONE (200 mg/1) LEVODOPA (75 mg/1)

Linked Drug Pages (1)

Stalevo ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "37d4ceb8-10e7-0fa8-7171-077b2cd6affd", "openfda": {"nui": ["N0000175754", "N0000175755", "N0000175756", "N0000175757", "N0000193220", "M0370111"], "upc": ["0352427805011", "0352427809019"], "unii": ["MNX7R8C5VO", "4975G9NM6T", "46627O600J"], "rxcui": ["403850", "403851", "403852", "404551", "404552", "404553", "730988", "730992", "810083", "810087", "810090", "810094"], "spl_set_id": ["53c488d8-4146-7563-8021-d90c931d1a95"], "pharm_class_cs": ["Amino Acids, Aromatic [CS]"], "pharm_class_epc": ["Aromatic Amino Acid Decarboxylation Inhibitor [EPC]", "Catechol-O-Methyltransferase Inhibitor [EPC]", "Aromatic Amino Acid [EPC]"], "pharm_class_moa": ["DOPA Decarboxylase Inhibitors [MoA]", "Catechol O-Methyltransferase Inhibitors [MoA]"], "manufacturer_name": ["Almatica Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (52427-809-01)  / 100 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "52427-809-01", "marketing_end_date": "20260228", "marketing_start_date": "20201005"}], "brand_name": "Stalevo", "product_id": "52427-809_37d4ceb8-10e7-0fa8-7171-077b2cd6affd", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]", "Catechol O-Methyltransferase Inhibitors [MoA]", "Catechol-O-Methyltransferase Inhibitor [EPC]"], "product_ndc": "52427-809", "generic_name": "carbidopa, levodopa, and entacapone", "labeler_name": "Almatica Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Stalevo", "active_ingredients": [{"name": "CARBIDOPA", "strength": "18.75 mg/1"}, {"name": "ENTACAPONE", "strength": "200 mg/1"}, {"name": "LEVODOPA", "strength": "75 mg/1"}], "application_number": "NDA021485", "marketing_category": "NDA", "marketing_end_date": "20260228", "marketing_start_date": "20201005"}