carbidopa and levodopa (42291-471)

Drug Facts

Product Profile

Brand Name carbidopa and levodopa

Generic Name carbidopa and levodopa

Labeler avkare

Dosage Form TABLET

Routes

ORAL

Active Ingredients

carbidopa 10 mg/1, levodopa 100 mg/1

Manufacturer

AvKARE

Identifiers & Regulatory

Product NDC 42291-471

Product ID 42291-471_485d7c0e-be0a-f880-e063-6294a90aacb8

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA074260

Listing Expiration 2027-12-31

Marketing Start 2022-06-24

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 42291471

Hyphenated Format 42291-471

Supplemental Identifiers

RxCUI

197443

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 ANDA074260 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1
100 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (42291-471-01)
500 TABLET in 1 BOTTLE (42291-471-50)

source: ndc

Packages (2)

42291-471-01 100 TABLET in 1 BOTTLE (42291-471-01) 42291-471-50 500 TABLET in 1 BOTTLE (42291-471-50)

Ingredients (2)

carbidopa (10 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": "485d7c0e-be0a-f880-e063-6294a90aacb8", "openfda": {"nui": ["N0000175754", "N0000175755", "N0000193220", "M0370111"], "unii": ["MNX7R8C5VO", "46627O600J"], "rxcui": ["197443"], "spl_set_id": ["e232e055-7892-3541-e053-2995a90a1e74"], "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": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42291-471-01)", "package_ndc": "42291-471-01", "marketing_start_date": "20220624"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (42291-471-50)", "package_ndc": "42291-471-50", "marketing_start_date": "20220624"}], "brand_name": "Carbidopa and levodopa", "product_id": "42291-471_485d7c0e-be0a-f880-e063-6294a90aacb8", "dosage_form": "TABLET", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]"], "product_ndc": "42291-471", "generic_name": "Carbidopa and levodopa", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbidopa and levodopa", "active_ingredients": [{"name": "CARBIDOPA", "strength": "10 mg/1"}, {"name": "LEVODOPA", "strength": "100 mg/1"}], "application_number": "ANDA074260", "marketing_category": "ANDA", "marketing_start_date": "20220624", "listing_expiration_date": "20271231"}