carbidopa, levodopa, and entacapone (0781-5654)

Drug Facts

Product Profile

Brand Name carbidopa, levodopa, and entacapone

Generic Name carbidopa, levodopa, and entacapone

Labeler sandoz inc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

carbidopa 37.5 mg/1, entacapone 200 mg/1, levodopa 150 mg/1

Manufacturer

Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-5654

Product ID 0781-5654_3aec3da3-a8fc-4996-b2e2-3d4f029e35cf

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA AUTHORIZED GENERIC

Application Number NDA021485

Listing Expiration 2026-12-31

Marketing Start 2014-06-18

Pharmacologic Class

Established (EPC)

aromatic amino acid [epc] catechol-o-methyltransferase inhibitor [epc] aromatic amino acid decarboxylation inhibitor [epc]

Mechanism of Action

catechol o-methyltransferase inhibitors [moa] dopa decarboxylase inhibitors [moa]

Chemical Structure

amino acids, aromatic [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07815654

Hyphenated Format 0781-5654

Supplemental Identifiers

RxCUI

403850 403851 403852 730988 810083 810090

UPC

0307815625016

UNII

46627O600J 4975G9NM6T MNX7R8C5VO

NUI

N0000193220 M0370111 N0000175756 N0000175757 N0000175754 N0000175755

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 carbidopa, levodopa, and entacapone (source: ndc)

Generic Name carbidopa, levodopa, and entacapone (source: ndc)

Application Number NDA021485 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

37.5 mg/1
200 mg/1
150 mg/1

source: ndc

Packaging

100 TABLET, FILM COATED in 1 BOTTLE (0781-5654-01)

source: ndc

Packages (1)

0781-5654-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-5654-01)

Ingredients (3)

carbidopa (37.5 mg/1) entacapone (200 mg/1) levodopa (150 mg/1)

Linked Drug Pages (1)

Carbidopa, Levodopa, and Entacapone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "3aec3da3-a8fc-4996-b2e2-3d4f029e35cf", "openfda": {"nui": ["N0000193220", "M0370111", "N0000175756", "N0000175757", "N0000175754", "N0000175755"], "upc": ["0307815625016"], "unii": ["46627O600J", "4975G9NM6T", "MNX7R8C5VO"], "rxcui": ["403850", "403851", "403852", "730988", "810083", "810090"], "spl_set_id": ["9c16c0e0-3b97-486b-b7d5-579f5853e2c5"], "pharm_class_cs": ["Amino Acids, Aromatic [CS]"], "pharm_class_epc": ["Aromatic Amino Acid [EPC]", "Catechol-O-Methyltransferase Inhibitor [EPC]", "Aromatic Amino Acid Decarboxylation Inhibitor [EPC]"], "pharm_class_moa": ["Catechol O-Methyltransferase Inhibitors [MoA]", "DOPA Decarboxylase Inhibitors [MoA]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0781-5654-01)", "package_ndc": "0781-5654-01", "marketing_start_date": "20140618"}], "brand_name": "Carbidopa, Levodopa, and Entacapone", "product_id": "0781-5654_3aec3da3-a8fc-4996-b2e2-3d4f029e35cf", "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": "0781-5654", "generic_name": "Carbidopa, Levodopa, and Entacapone", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbidopa, Levodopa, and Entacapone", "active_ingredients": [{"name": "CARBIDOPA", "strength": "37.5 mg/1"}, {"name": "ENTACAPONE", "strength": "200 mg/1"}, {"name": "LEVODOPA", "strength": "150 mg/1"}], "application_number": "NDA021485", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20140618", "listing_expiration_date": "20261231"}