carbidopa and levodopa (59651-458)

Drug Facts

Product Profile

Brand Name carbidopa and levodopa

Generic Name carbidopa and levodopa

Labeler aurobindo pharma limited

Dosage Form TABLET

Routes

ORAL

Active Ingredients

carbidopa 25 mg/1, levodopa 250 mg/1

Manufacturer

Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-458

Product ID 59651-458_a887b72a-8896-48b9-8e91-9d4bb49faaed

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 [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 59651458

Hyphenated Format 59651-458

Supplemental Identifiers

RxCUI

197443 197444 197445

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 ANDA216537 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1
250 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (59651-458-01)
500 TABLET in 1 BOTTLE (59651-458-05)
1000 TABLET in 1 BOTTLE (59651-458-99)

source: ndc

Packages (3)

59651-458-01 100 TABLET in 1 BOTTLE (59651-458-01) 59651-458-05 500 TABLET in 1 BOTTLE (59651-458-05) 59651-458-99 1000 TABLET in 1 BOTTLE (59651-458-99)

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": "a887b72a-8896-48b9-8e91-9d4bb49faaed", "openfda": {"nui": ["N0000193220", "M0370111", "N0000175754", "N0000175755"], "unii": ["46627O600J", "MNX7R8C5VO"], "rxcui": ["197443", "197444", "197445"], "spl_set_id": ["4ced8a05-27ac-463f-b331-387e473fdaa1"], "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": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (59651-458-01)", "package_ndc": "59651-458-01", "marketing_start_date": "20221128"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (59651-458-05)", "package_ndc": "59651-458-05", "marketing_start_date": "20221128"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (59651-458-99)", "package_ndc": "59651-458-99", "marketing_start_date": "20221128"}], "brand_name": "Carbidopa and Levodopa", "product_id": "59651-458_a887b72a-8896-48b9-8e91-9d4bb49faaed", "dosage_form": "TABLET", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]"], "product_ndc": "59651-458", "generic_name": "Carbidopa and Levodopa", "labeler_name": "Aurobindo Pharma Limited", "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"}