carbidopa and levodopa

Generic: carbidopa and levodopa

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbidopa and levodopa
Generic Name carbidopa and levodopa
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

carbidopa 25 mg/1, levodopa 250 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-4134
Product ID 63629-4134_ff612022-6924-42dc-b4cb-bb0d16c209f7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216537
Listing Expiration 2026-12-31
Marketing Start 2022-11-28

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 636294134
Hyphenated Format 63629-4134

Supplemental Identifiers

RxCUI
197445
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
  • 25 mg/1
  • 250 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (63629-4134-1)
  • 270 TABLET in 1 BOTTLE (63629-4134-2)
  • 60 TABLET in 1 BOTTLE (63629-4134-3)
source: ndc

Packages (3)

63629-4134-1 30 TABLET in 1 BOTTLE (63629-4134-1) 63629-4134-2 270 TABLET in 1 BOTTLE (63629-4134-2) 63629-4134-3 60 TABLET in 1 BOTTLE (63629-4134-3)

Ingredients (2)

carbidopa (25 mg/1) levodopa (250 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": "ff612022-6924-42dc-b4cb-bb0d16c209f7", "openfda": {"nui": ["N0000175754", "N0000175755", "N0000193220", "M0370111"], "unii": ["MNX7R8C5VO", "46627O600J"], "rxcui": ["197445"], "spl_set_id": ["998f805d-da97-484e-a931-e409e8b8c65a"], "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": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (63629-4134-1)", "package_ndc": "63629-4134-1", "marketing_start_date": "20250407"}, {"sample": false, "description": "270 TABLET in 1 BOTTLE (63629-4134-2)", "package_ndc": "63629-4134-2", "marketing_start_date": "20250407"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (63629-4134-3)", "package_ndc": "63629-4134-3", "marketing_start_date": "20250407"}], "brand_name": "Carbidopa and Levodopa", "product_id": "63629-4134_ff612022-6924-42dc-b4cb-bb0d16c209f7", "dosage_form": "TABLET", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]"], "product_ndc": "63629-4134", "generic_name": "Carbidopa and Levodopa", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbidopa and Levodopa", "active_ingredients": [{"name": "CARBIDOPA", "strength": "25 mg/1"}, {"name": "LEVODOPA", "strength": "250 mg/1"}], "application_number": "ANDA216537", "marketing_category": "ANDA", "marketing_start_date": "20221128", "listing_expiration_date": "20261231"}