carbidopa and levodopa (0378-0085)

Drug Facts

Product Profile

Brand Name carbidopa and levodopa

Generic Name carbidopa and levodopa

Labeler mylan pharmaceuticals inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

carbidopa 25 mg/1, levodopa 100 mg/1

Manufacturer

Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-0085

Product ID 0378-0085_b022f0de-c358-46a0-b5e1-18724d7e706f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA090324

Marketing Start 2011-05-16

Marketing End 2026-04-30

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 03780085

Hyphenated Format 0378-0085

Supplemental Identifiers

RxCUI

197443 197444 197445

UNII

MNX7R8C5VO 46627O600J

NUI

N0000175754 N0000175755 N0000193220 M0370111

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 ANDA090324 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1
100 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE, PLASTIC (0378-0085-01)

source: ndc

Packages (1)

0378-0085-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0085-01)

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": "b022f0de-c358-46a0-b5e1-18724d7e706f", "openfda": {"nui": ["N0000175754", "N0000175755", "N0000193220", "M0370111"], "unii": ["MNX7R8C5VO", "46627O600J"], "rxcui": ["197443", "197444", "197445"], "spl_set_id": ["3c768639-8a70-4d12-ad93-827bb42ec6b7"], "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": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0085-01)", "package_ndc": "0378-0085-01", "marketing_end_date": "20260430", "marketing_start_date": "20110516"}], "brand_name": "Carbidopa and Levodopa", "product_id": "0378-0085_b022f0de-c358-46a0-b5e1-18724d7e706f", "dosage_form": "TABLET", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]"], "product_ndc": "0378-0085", "generic_name": "carbidopa and levodopa", "labeler_name": "Mylan Pharmaceuticals Inc.", "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": "ANDA090324", "marketing_category": "ANDA", "marketing_end_date": "20260430", "marketing_start_date": "20110516"}