carbidopa and levodopa (60219-2034)

Drug Facts

Product Profile

Brand Name carbidopa and levodopa

Generic Name carbidopa and levodopa

Labeler amneal pharmaceuticals ny llc

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

carbidopa 50 mg/1, levodopa 200 mg/1

Manufacturer

Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 60219-2034

Product ID 60219-2034_3979736e-dac3-41a1-a3d7-d17b593a56da

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA076521

Listing Expiration 2026-12-31

Marketing Start 2022-12-21

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 602192034

Hyphenated Format 60219-2034

Supplemental Identifiers

RxCUI

308988 308989

UPC

0360219203310 0360219203419

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 ANDA076521 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

50 mg/1
200 mg/1

source: ndc

Packaging

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60219-2034-1)
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (60219-2034-3)
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (60219-2034-5)

source: ndc

Packages (3)

60219-2034-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60219-2034-1) 60219-2034-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (60219-2034-3) 60219-2034-5 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (60219-2034-5)

Ingredients (2)

carbidopa (50 mg/1) levodopa (200 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": "3979736e-dac3-41a1-a3d7-d17b593a56da", "openfda": {"nui": ["N0000193220", "M0370111", "N0000175754", "N0000175755"], "upc": ["0360219203310", "0360219203419"], "unii": ["46627O600J", "MNX7R8C5VO"], "rxcui": ["308988", "308989"], "spl_set_id": ["0eb24333-3c11-41dd-888d-3a30d3c9d188"], "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": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60219-2034-1)", "package_ndc": "60219-2034-1", "marketing_start_date": "20221221"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (60219-2034-3)", "package_ndc": "60219-2034-3", "marketing_start_date": "20221221"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (60219-2034-5)", "package_ndc": "60219-2034-5", "marketing_start_date": "20221221"}], "brand_name": "Carbidopa and Levodopa", "product_id": "60219-2034_3979736e-dac3-41a1-a3d7-d17b593a56da", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]"], "product_ndc": "60219-2034", "generic_name": "CARBIDOPA and LEVODOPA", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbidopa and Levodopa", "active_ingredients": [{"name": "CARBIDOPA", "strength": "50 mg/1"}, {"name": "LEVODOPA", "strength": "200 mg/1"}], "application_number": "ANDA076521", "marketing_category": "ANDA", "marketing_start_date": "20221221", "listing_expiration_date": "20261231"}