carbidopa and levodopa (16729-078)

Drug Facts

Product Profile

Brand Name carbidopa and levodopa

Generic Name carbidopa and levodopa

Labeler accord healthcare, inc.

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

carbidopa 25 mg/1, levodopa 100 mg/1

Manufacturer

Accord Healthcare, Inc.

Identifiers & Regulatory

Product NDC 16729-078

Product ID 16729-078_40a9fe53-d24b-d4ad-e063-6294a90aeff5

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202323

Listing Expiration 2026-12-31

Marketing Start 2013-06-13

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 16729078

Hyphenated Format 16729-078

Supplemental Identifiers

RxCUI

308988 308989

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 ANDA202323 (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 (16729-078-01)
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-078-17)

source: ndc

Packages (2)

16729-078-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-078-01) 16729-078-17 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-078-17)

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": "40a9fe53-d24b-d4ad-e063-6294a90aeff5", "openfda": {"nui": ["N0000193220", "M0370111", "N0000175754", "N0000175755"], "unii": ["46627O600J", "MNX7R8C5VO"], "rxcui": ["308988", "308989"], "spl_set_id": ["5217a6ec-cc26-4acc-b2da-17f6545c3b60"], "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": ["Accord Healthcare, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-078-01)", "package_ndc": "16729-078-01", "marketing_start_date": "20130613"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-078-17)", "package_ndc": "16729-078-17", "marketing_start_date": "20131031"}], "brand_name": "CARBIDOPA AND LEVODOPA", "product_id": "16729-078_40a9fe53-d24b-d4ad-e063-6294a90aeff5", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]"], "product_ndc": "16729-078", "generic_name": "Carbidopa and Levodopa", "labeler_name": "Accord Healthcare, 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": "ANDA202323", "marketing_category": "ANDA", "marketing_start_date": "20130613", "listing_expiration_date": "20261231"}