carbidopa-levodopa

Generic: carbidopa and levodopa

Labeler: trupharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

carbidopa 25 mg/1, levodopa 100 mg/1

Manufacturer
TruPharma, LLC

Identifiers & Regulatory

Product NDC 52817-391
Product ID 52817-391_f8d2095e-d709-7b97-e053-6294a90af7d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216505
Listing Expiration 2026-12-31
Marketing Start 2022-09-21

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 52817391
Hyphenated Format 52817-391

Supplemental Identifiers

RxCUI
197443 197444 197445
UPC
0352817390103 0352817391506 0352817392008 0352817391100 0352817390509 0352817391001 0352817392503
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-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
  • 1000 TABLET in 1 BOTTLE (52817-391-00)
  • 100 TABLET in 1 BOTTLE (52817-391-10)
  • 500 TABLET in 1 BOTTLE (52817-391-50)
source: ndc

Packages (3)

52817-391-00 1000 TABLET in 1 BOTTLE (52817-391-00) 52817-391-10 100 TABLET in 1 BOTTLE (52817-391-10) 52817-391-50 500 TABLET in 1 BOTTLE (52817-391-50)

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": "f8d2095e-d709-7b97-e053-6294a90af7d6", "openfda": {"nui": ["N0000193220", "M0370111", "N0000175754", "N0000175755"], "upc": ["0352817390103", "0352817391506", "0352817392008", "0352817391100", "0352817390509", "0352817391001", "0352817392503"], "unii": ["46627O600J", "MNX7R8C5VO"], "rxcui": ["197443", "197444", "197445"], "spl_set_id": ["d1bb319b-82a3-4b66-9cdc-f77fdb8383ce"], "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": ["TruPharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (52817-391-00)", "package_ndc": "52817-391-00", "marketing_start_date": "20230404"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (52817-391-10)", "package_ndc": "52817-391-10", "marketing_start_date": "20230404"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (52817-391-50)", "package_ndc": "52817-391-50", "marketing_start_date": "20230404"}], "brand_name": "Carbidopa-levodopa", "product_id": "52817-391_f8d2095e-d709-7b97-e053-6294a90af7d6", "dosage_form": "TABLET", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]"], "product_ndc": "52817-391", "generic_name": "carbidopa and levodopa", "labeler_name": "TruPharma, 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": "20220921", "listing_expiration_date": "20261231"}