carbidopa and levodopa (67046-1614)

Drug Facts

Product Profile

Brand Name carbidopa and levodopa

Generic Name carbidopa and levodopa

Labeler coupler llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

carbidopa 10 mg/1, levodopa 100 mg/1

Manufacturer

Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1614

Product ID 67046-1614_43ce4d9e-fb3c-ed29-e063-6294a90a99ca

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA216537

Listing Expiration 2026-12-31

Marketing Start 2025-11-17

Pharmacologic Class

Established (EPC)

aromatic amino acid decarboxylation inhibitor [epc] aromatic amino acid [epc]

Mechanism of Action

dopa decarboxylase inhibitors [moa]

Chemical Structure

amino acids, aromatic [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461614

Hyphenated Format 67046-1614

Supplemental Identifiers

RxCUI

197443

UNII

MNX7R8C5VO 46627O600J

NUI

N0000175754 N0000175755 N0000193220 M0370111

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 and levodopa (source: ndc)

Generic Name carbidopa and levodopa (source: ndc)

Application Number ANDA216537 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1
100 mg/1

source: ndc

Packaging

30 TABLET in 1 BLISTER PACK (67046-1614-3)

source: ndc

Packages (1)

67046-1614-3 30 TABLET in 1 BLISTER PACK (67046-1614-3)

Ingredients (2)

carbidopa (10 mg/1) levodopa (100 mg/1)

Linked Drug Pages (1)

Carbidopa and Levodopa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "43ce4d9e-fb3c-ed29-e063-6294a90a99ca", "openfda": {"nui": ["N0000175754", "N0000175755", "N0000193220", "M0370111"], "unii": ["MNX7R8C5VO", "46627O600J"], "rxcui": ["197443"], "spl_set_id": ["43ce5061-0830-6f4f-e063-6394a90afc59"], "pharm_class_cs": ["Amino Acids, Aromatic [CS]"], "pharm_class_epc": ["Aromatic Amino Acid Decarboxylation Inhibitor [EPC]", "Aromatic Amino Acid [EPC]"], "pharm_class_moa": ["DOPA Decarboxylase Inhibitors [MoA]"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1614-3)", "package_ndc": "67046-1614-3", "marketing_start_date": "20251117"}], "brand_name": "Carbidopa and Levodopa", "product_id": "67046-1614_43ce4d9e-fb3c-ed29-e063-6294a90a99ca", "dosage_form": "TABLET", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]"], "product_ndc": "67046-1614", "generic_name": "Carbidopa and Levodopa", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbidopa and Levodopa", "active_ingredients": [{"name": "CARBIDOPA", "strength": "10 mg/1"}, {"name": "LEVODOPA", "strength": "100 mg/1"}], "application_number": "ANDA216537", "marketing_category": "ANDA", "marketing_start_date": "20251117", "listing_expiration_date": "20261231"}