carbidopa, levodopa and entacapone (33342-492)

Drug Facts

Product Profile

Brand Name carbidopa, levodopa and entacapone

Generic Name carbidopa, levodopa and entacapone

Labeler macleods pharmaceuticals limited

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

carbidopa 18.75 mg/1, entacapone 200 mg/1, levodopa 75 mg/1

Manufacturer

Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-492

Product ID 33342-492_f0d9d7a8-1d06-4119-b2bc-42b3ec08d45b

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA214495

Listing Expiration 2026-12-31

Marketing Start 2025-04-15

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 33342492

Hyphenated Format 33342-492

Supplemental Identifiers

RxCUI

403850 403851 403852 730988 810083 810090

UPC

0333342491121 0333342496119 0333342492128 0333342496126 0333342491114 0333342493125 0333342495112 0333342493118 0333342495129 0333342492111 0333342494122 0333342494115

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 ANDA214495 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

18.75 mg/1
200 mg/1
75 mg/1

source: ndc

Packaging

100 TABLET, FILM COATED in 1 BOTTLE (33342-492-11)
10 BLISTER PACK in 1 CARTON (33342-492-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK

source: ndc

Packages (2)

33342-492-11 100 TABLET, FILM COATED in 1 BOTTLE (33342-492-11) 33342-492-12 10 BLISTER PACK in 1 CARTON (33342-492-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (3)

carbidopa (18.75 mg/1) entacapone (200 mg/1) levodopa (75 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": "f0d9d7a8-1d06-4119-b2bc-42b3ec08d45b", "openfda": {"nui": ["N0000193220", "M0370111", "N0000175756", "N0000175757", "N0000175754", "N0000175755"], "upc": ["0333342491121", "0333342496119", "0333342492128", "0333342496126", "0333342491114", "0333342493125", "0333342495112", "0333342493118", "0333342495129", "0333342492111", "0333342494122", "0333342494115"], "unii": ["46627O600J", "4975G9NM6T", "MNX7R8C5VO"], "rxcui": ["403850", "403851", "403852", "730988", "810083", "810090"], "spl_set_id": ["f0d9d7a8-1d06-4119-b2bc-42b3ec08d45b"], "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": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (33342-492-11)", "package_ndc": "33342-492-11", "marketing_start_date": "20250415"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-492-12)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "33342-492-12", "marketing_start_date": "20250415"}], "brand_name": "Carbidopa, Levodopa and Entacapone", "product_id": "33342-492_f0d9d7a8-1d06-4119-b2bc-42b3ec08d45b", "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": "33342-492", "generic_name": "Carbidopa, Levodopa and Entacapone", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbidopa, Levodopa and Entacapone", "active_ingredients": [{"name": "CARBIDOPA", "strength": "18.75 mg/1"}, {"name": "ENTACAPONE", "strength": "200 mg/1"}, {"name": "LEVODOPA", "strength": "75 mg/1"}], "application_number": "ANDA214495", "marketing_category": "ANDA", "marketing_start_date": "20250415", "listing_expiration_date": "20261231"}