carbidopa-levodopa

Generic: carbidopa and levodopa

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbidopa-levodopa
Generic Name carbidopa and levodopa
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

carbidopa 25 mg/1, levodopa 100 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1507
Product ID 67046-1507_2cdcb5e6-b724-c955-e063-6294a90af382
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216505
Listing Expiration 2026-12-31
Marketing Start 2025-01-29

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 670461507
Hyphenated Format 67046-1507

Supplemental Identifiers

RxCUI
197444
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-levodopa (source: ndc)
Generic Name carbidopa and levodopa (source: ndc)
Application Number ANDA216505 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1507-3)
source: ndc

Packages (1)

67046-1507-3 30 TABLET in 1 BLISTER PACK (67046-1507-3)

Ingredients (2)

carbidopa (25 mg/1) levodopa (100 mg/1)

Linked Drug Pages (1)

Carbidopa-levodopa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2cdcb5e6-b724-c955-e063-6294a90af382", "openfda": {"nui": ["N0000175754", "N0000175755", "N0000193220", "M0370111"], "unii": ["MNX7R8C5VO", "46627O600J"], "rxcui": ["197444"], "spl_set_id": ["2cdca970-f077-3a80-e063-6294a90ab335"], "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 (67046-1507-3)", "package_ndc": "67046-1507-3", "marketing_start_date": "20250129"}], "brand_name": "Carbidopa-levodopa", "product_id": "67046-1507_2cdcb5e6-b724-c955-e063-6294a90af382", "dosage_form": "TABLET", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]"], "product_ndc": "67046-1507", "generic_name": "carbidopa and levodopa", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbidopa-levodopa", "active_ingredients": [{"name": "CARBIDOPA", "strength": "25 mg/1"}, {"name": "LEVODOPA", "strength": "100 mg/1"}], "application_number": "ANDA216505", "marketing_category": "ANDA", "marketing_start_date": "20250129", "listing_expiration_date": "20261231"}