carbidopa and levodopa (16571-158)

Drug Facts

Product Profile

Brand Name carbidopa and levodopa

Generic Name carbidopa and levodopa

Labeler rising pharma holdings, inc.

Dosage Form TABLET, ORALLY DISINTEGRATING

Routes

ORAL

Active Ingredients

carbidopa 25 mg/1, levodopa 100 mg/1

Manufacturer

Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-158

Product ID 16571-158_bf8b1cec-9b24-4102-b948-08c988bfca91

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA078893

Listing Expiration 2027-12-31

Marketing Start 2025-01-08

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 16571158

Hyphenated Format 16571-158

Supplemental Identifiers

RxCUI

476399 476515 483090

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 ANDA078893 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1
100 mg/1

source: ndc

Packaging

100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (16571-158-01)

source: ndc

Packages (1)

16571-158-01 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (16571-158-01)

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": "bf8b1cec-9b24-4102-b948-08c988bfca91", "openfda": {"nui": ["N0000193220", "M0370111", "N0000175754", "N0000175755"], "unii": ["46627O600J", "MNX7R8C5VO"], "rxcui": ["476399", "476515", "483090"], "spl_set_id": ["302bfe03-d222-4a87-80ff-f2dbfb9a07f4"], "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": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (16571-158-01)", "package_ndc": "16571-158-01", "marketing_start_date": "20250108"}], "brand_name": "Carbidopa and Levodopa", "product_id": "16571-158_bf8b1cec-9b24-4102-b948-08c988bfca91", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]"], "product_ndc": "16571-158", "generic_name": "carbidopa and levodopa", "labeler_name": "Rising Pharma Holdings, 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": "ANDA078893", "marketing_category": "ANDA", "marketing_start_date": "20250108", "listing_expiration_date": "20271231"}