carbidopa and levodopa

Generic: carbidopa and levodopa

Labeler: sciegen pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbidopa and levodopa
Generic Name carbidopa and levodopa
Labeler sciegen pharmaceuticals inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

carbidopa 25 mg/1, levodopa 250 mg/1

Manufacturer
ScieGen Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 50228-459
Product ID 50228-459_f1b1f43e-9775-0570-e053-2995a90ae404
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214092
Listing Expiration 2026-12-31
Marketing Start 2021-05-07

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 50228459
Hyphenated Format 50228-459

Supplemental Identifiers

RxCUI
197443 197444 197445
UPC
0350228457057 0350228457019 0350228457309 0350228458306 0350228459303 0350228459013 0350228458054 0350228459051 0350228458108 0350228458016
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 carbidopa and levodopa (source: ndc)
Generic Name carbidopa and levodopa (source: ndc)
Application Number ANDA214092 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (50228-459-01)
  • 500 TABLET in 1 BOTTLE (50228-459-05)
  • 1000 TABLET in 1 BOTTLE (50228-459-10)
  • 30 TABLET in 1 BOTTLE (50228-459-30)
source: ndc

Packages (4)

50228-459-01 100 TABLET in 1 BOTTLE (50228-459-01) 50228-459-05 500 TABLET in 1 BOTTLE (50228-459-05) 50228-459-10 1000 TABLET in 1 BOTTLE (50228-459-10) 50228-459-30 30 TABLET in 1 BOTTLE (50228-459-30)

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": "f1b1f43e-9775-0570-e053-2995a90ae404", "openfda": {"nui": ["N0000193220", "M0370111", "N0000175754", "N0000175755"], "upc": ["0350228457057", "0350228457019", "0350228457309", "0350228458306", "0350228459303", "0350228459013", "0350228458054", "0350228459051", "0350228458108", "0350228458016"], "unii": ["46627O600J", "MNX7R8C5VO"], "rxcui": ["197443", "197444", "197445"], "spl_set_id": ["a32afa84-7bc0-4bd3-bc50-55d738f3d7ce"], "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": ["ScieGen Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (50228-459-01)", "package_ndc": "50228-459-01", "marketing_start_date": "20210507"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (50228-459-05)", "package_ndc": "50228-459-05", "marketing_start_date": "20210507"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (50228-459-10)", "package_ndc": "50228-459-10", "marketing_start_date": "20210507"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (50228-459-30)", "package_ndc": "50228-459-30", "marketing_start_date": "20210507"}], "brand_name": "Carbidopa and Levodopa", "product_id": "50228-459_f1b1f43e-9775-0570-e053-2995a90ae404", "dosage_form": "TABLET", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]"], "product_ndc": "50228-459", "generic_name": "Carbidopa and Levodopa", "labeler_name": "ScieGen Pharmaceuticals Inc", "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": "ANDA214092", "marketing_category": "ANDA", "marketing_start_date": "20210507", "listing_expiration_date": "20261231"}