carbidopa, levodopa and entacapone

Generic: carbidopa, levodopa and entacapone

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbidopa, levodopa and entacapone
Generic Name carbidopa, levodopa and entacapone
Labeler rising pharma holdings, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

carbidopa 18.75 mg/1, entacapone 200 mg/1, levodopa 75 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-690
Product ID 16571-690_c31e5132-af44-4300-a5ed-62deb8e62efc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213212
Listing Expiration 2026-12-31
Marketing Start 2021-08-05

Pharmacologic Class

Established (EPC)
aromatic amino acid [epc] catechol-o-methyltransferase inhibitor [epc] aromatic amino acid decarboxylation inhibitor [epc]
Mechanism of Action
catechol o-methyltransferase inhibitors [moa] dopa decarboxylase inhibitors [moa]
Chemical Structure
amino acids, aromatic [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571690
Hyphenated Format 16571-690

Supplemental Identifiers

RxCUI
403850 403851 403852 730988 810083 810090
UPC
0316571690015 0316571694013 0316571692019 0316571691012 0316571693016
UNII
46627O600J 4975G9NM6T MNX7R8C5VO
NUI
N0000193220 M0370111 N0000175756 N0000175757 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, levodopa and entacapone (source: ndc)
Generic Name carbidopa, levodopa and entacapone (source: ndc)
Application Number ANDA213212 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 18.75 mg/1
  • 200 mg/1
  • 75 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (16571-690-01)
source: ndc

Packages (1)

16571-690-01 100 TABLET, FILM COATED in 1 BOTTLE (16571-690-01)

Ingredients (3)

carbidopa (18.75 mg/1) entacapone (200 mg/1) levodopa (75 mg/1)

Linked Drug Pages (1)

CARBIDOPA, LEVODOPA AND ENTACAPONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c31e5132-af44-4300-a5ed-62deb8e62efc", "openfda": {"nui": ["N0000193220", "M0370111", "N0000175756", "N0000175757", "N0000175754", "N0000175755"], "upc": ["0316571690015", "0316571694013", "0316571692019", "0316571691012", "0316571693016"], "unii": ["46627O600J", "4975G9NM6T", "MNX7R8C5VO"], "rxcui": ["403850", "403851", "403852", "730988", "810083", "810090"], "spl_set_id": ["2f8e82d7-6baf-456a-b8c3-4fda6e317902"], "pharm_class_cs": ["Amino Acids, Aromatic [CS]"], "pharm_class_epc": ["Aromatic Amino Acid [EPC]", "Catechol-O-Methyltransferase Inhibitor [EPC]", "Aromatic Amino Acid Decarboxylation Inhibitor [EPC]"], "pharm_class_moa": ["Catechol O-Methyltransferase Inhibitors [MoA]", "DOPA Decarboxylase Inhibitors [MoA]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (16571-690-01)", "package_ndc": "16571-690-01", "marketing_start_date": "20210805"}], "brand_name": "CARBIDOPA, LEVODOPA AND ENTACAPONE", "product_id": "16571-690_c31e5132-af44-4300-a5ed-62deb8e62efc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]", "Catechol O-Methyltransferase Inhibitors [MoA]", "Catechol-O-Methyltransferase Inhibitor [EPC]"], "product_ndc": "16571-690", "generic_name": "CARBIDOPA, LEVODOPA AND ENTACAPONE", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CARBIDOPA, LEVODOPA AND ENTACAPONE", "active_ingredients": [{"name": "CARBIDOPA", "strength": "18.75 mg/1"}, {"name": "ENTACAPONE", "strength": "200 mg/1"}, {"name": "LEVODOPA", "strength": "75 mg/1"}], "application_number": "ANDA213212", "marketing_category": "ANDA", "marketing_start_date": "20210805", "listing_expiration_date": "20261231"}