sinemet

Generic: carbidopa and levodopa

Labeler: organon llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sinemet
Generic Name carbidopa and levodopa
Labeler organon llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

carbidopa 25 mg/1, levodopa 250 mg/1

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-167
Product ID 78206-167_3ef49101-ada4-431d-9ada-d5b8c2be7283
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017555
Listing Expiration 2026-12-31
Marketing Start 2021-06-01

Pharmacologic Class

Established (EPC)
aromatic amino acid [epc] aromatic amino acid decarboxylation inhibitor [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 78206167
Hyphenated Format 78206-167

Supplemental Identifiers

RxCUI
197443 197444 197445 724598 724602 724606
UPC
0378206168016 0378206190017 0378206167019 0378206166012
UNII
46627O600J MNX7R8C5VO
NUI
N0000193220 M0370111 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 sinemet (source: ndc)
Generic Name carbidopa and levodopa (source: ndc)
Application Number NDA017555 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (78206-167-01)
source: ndc

Packages (1)

78206-167-01 100 TABLET in 1 BOTTLE (78206-167-01)

Ingredients (2)

carbidopa (25 mg/1) levodopa (250 mg/1)

Linked Drug Pages (1)

SINEMET ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3ef49101-ada4-431d-9ada-d5b8c2be7283", "openfda": {"nui": ["N0000193220", "M0370111", "N0000175754", "N0000175755"], "upc": ["0378206168016", "0378206190017", "0378206167019", "0378206166012"], "unii": ["46627O600J", "MNX7R8C5VO"], "rxcui": ["197443", "197444", "197445", "724598", "724602", "724606"], "spl_set_id": ["9b17b028-964a-473c-823d-81423535bd66"], "pharm_class_cs": ["Amino Acids, Aromatic [CS]"], "pharm_class_epc": ["Aromatic Amino Acid [EPC]", "Aromatic Amino Acid Decarboxylation Inhibitor [EPC]"], "pharm_class_moa": ["DOPA Decarboxylase Inhibitors [MoA]"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (78206-167-01)", "package_ndc": "78206-167-01", "marketing_start_date": "20210601"}], "brand_name": "SINEMET", "product_id": "78206-167_3ef49101-ada4-431d-9ada-d5b8c2be7283", "dosage_form": "TABLET", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]"], "product_ndc": "78206-167", "generic_name": "carbidopa and levodopa", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SINEMET", "active_ingredients": [{"name": "CARBIDOPA", "strength": "25 mg/1"}, {"name": "LEVODOPA", "strength": "250 mg/1"}], "application_number": "NDA017555", "marketing_category": "NDA", "marketing_start_date": "20210601", "listing_expiration_date": "20261231"}