carbidopa and levodopa

Generic: carbidopa and levodopa

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbidopa and levodopa
Generic Name carbidopa and levodopa
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

carbidopa 25 mg/1, levodopa 100 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-647
Product ID 71610-647_188d3827-60b2-4893-a8db-21433377eb1c
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 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 71610647
Hyphenated Format 71610-647

Supplemental Identifiers

RxCUI
197444
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 ANDA214092 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 100 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (71610-647-60)
  • 180 TABLET in 1 BOTTLE (71610-647-80)
source: ndc

Packages (2)

71610-647-60 90 TABLET in 1 BOTTLE (71610-647-60) 71610-647-80 180 TABLET in 1 BOTTLE (71610-647-80)

Ingredients (2)

carbidopa (25 mg/1) levodopa (100 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": "188d3827-60b2-4893-a8db-21433377eb1c", "openfda": {"nui": ["N0000175754", "N0000175755", "N0000193220", "M0370111"], "unii": ["MNX7R8C5VO", "46627O600J"], "rxcui": ["197444"], "spl_set_id": ["289ca0b7-1b4f-4653-b329-066447d18c13"], "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": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-647-60)", "package_ndc": "71610-647-60", "marketing_start_date": "20220502"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-647-80)", "package_ndc": "71610-647-80", "marketing_start_date": "20220502"}], "brand_name": "Carbidopa and Levodopa", "product_id": "71610-647_188d3827-60b2-4893-a8db-21433377eb1c", "dosage_form": "TABLET", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]"], "product_ndc": "71610-647", "generic_name": "Carbidopa and Levodopa", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbidopa and Levodopa", "active_ingredients": [{"name": "CARBIDOPA", "strength": "25 mg/1"}, {"name": "LEVODOPA", "strength": "100 mg/1"}], "application_number": "ANDA214092", "marketing_category": "ANDA", "marketing_start_date": "20210507", "listing_expiration_date": "20261231"}