carbidopa and levodopa (50228-460)

Drug Facts

Product Profile

Brand Name carbidopa and levodopa

Generic Name carbidopa and levodopa

Labeler sciegen pharmaceuticals inc

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

carbidopa 25 mg/1, levodopa 100 mg/1

Manufacturer

ScieGen Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 50228-460

Product ID 50228-460_cea3f5f1-014d-0c1d-e053-2995a90a7f01

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA214091

Listing Expiration 2026-12-31

Marketing Start 2021-10-05

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 50228460

Hyphenated Format 50228-460

Supplemental Identifiers

RxCUI

308988 308989

UPC

0350228460019 0350228461016 0350228460101 0350228461306 0350228460309

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 ANDA214091 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1
100 mg/1

source: ndc

Packaging

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-460-01)
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-460-10)
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-460-30)

source: ndc

Packages (3)

50228-460-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-460-01) 50228-460-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-460-10) 50228-460-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-460-30)

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": "cea3f5f1-014d-0c1d-e053-2995a90a7f01", "openfda": {"nui": ["N0000193220", "M0370111", "N0000175754", "N0000175755"], "upc": ["0350228460019", "0350228461016", "0350228460101", "0350228461306", "0350228460309"], "unii": ["46627O600J", "MNX7R8C5VO"], "rxcui": ["308988", "308989"], "spl_set_id": ["1b17ab1e-f3c1-4343-ba28-e2901cd97d43"], "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": ["ScieGen Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-460-01)", "package_ndc": "50228-460-01", "marketing_start_date": "20211005"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-460-10)", "package_ndc": "50228-460-10", "marketing_start_date": "20211005"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-460-30)", "package_ndc": "50228-460-30", "marketing_start_date": "20211005"}], "brand_name": "Carbidopa and Levodopa", "product_id": "50228-460_cea3f5f1-014d-0c1d-e053-2995a90a7f01", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]"], "product_ndc": "50228-460", "generic_name": "Carbidopa and Levodopa", "labeler_name": "ScieGen 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": "ANDA214091", "marketing_category": "ANDA", "marketing_start_date": "20211005", "listing_expiration_date": "20261231"}