carbidopa and levodopa (0615-8460)

Drug Facts

Product Profile

Brand Name carbidopa and levodopa

Generic Name carbidopa and levodopa

Labeler ncs healthcare of ky, llc dba vangard labs

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

carbidopa 25 mg/1, levodopa 100 mg/1

Manufacturer

NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8460

Product ID 0615-8460_bd08f206-2051-4ac7-b4ac-b0b83a79029d

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 06158460

Hyphenated Format 0615-8460

Supplemental Identifiers

RxCUI

308988 308989

UNII

46627O600J MNX7R8C5VO

NUI

N0000193220 M0370111 N0000175754 N0000175755

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

30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8460-39)

source: ndc

Packages (1)

0615-8460-39 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8460-39)

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": "bd08f206-2051-4ac7-b4ac-b0b83a79029d", "openfda": {"nui": ["N0000193220", "M0370111", "N0000175754", "N0000175755"], "unii": ["46627O600J", "MNX7R8C5VO"], "rxcui": ["308988", "308989"], "spl_set_id": ["ef0be743-e6f3-4662-8b0c-53f1eda4638a"], "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": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8460-39)", "package_ndc": "0615-8460-39", "marketing_start_date": "20230328"}], "brand_name": "Carbidopa and Levodopa", "product_id": "0615-8460_bd08f206-2051-4ac7-b4ac-b0b83a79029d", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]"], "product_ndc": "0615-8460", "generic_name": "Carbidopa and Levodopa", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "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"}