FDA.reportPublic FDA data

NDC 58177-383 - Carbidopa and Levodopa

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
58177-383
Package NDCs from labels
58177-383-19, 58177-383-09, 58177-383-11
Manufacturer
ETHEX
Effective date
2007-08-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Carbidopa and Levodopa - ETHEXETHEX2007-08-15Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58177-383-09Carbidopa and Levodopa1000 in 1 BOTTLETABLET, EXTENDED RELEASE10001
58177-383-11Carbidopa and Levodopa100 in 1 BOX, UNIT-DOSETABLET, EXTENDED RELEASE1001
58177-383-19Carbidopa and Levodopa30 in 1 BOTTLETABLET, EXTENDED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58177-383CARBIDOPA AND LEVODOPA (CARBIDOPA AND LEVODOPA) TABLET, EXTENDED RELEASE [ETHEX]13 package rows20080313_2f3b8f28-b3da-4658-bdc4-fe86dec62d32.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CarbidopaACTIVE INGREDIENTMNX7R8C5VOCARBIDOPA AND LEVODOPA (CARBIDOPA AND LEVODOPA) TABLET, EXTENDED RELEASE [ETHEX]1
LevodopaACTIVE INGREDIENT46627O600JCARBIDOPA AND LEVODOPA (CARBIDOPA AND LEVODOPA) TABLET, EXTENDED RELEASE [ETHEX]1
CarbidopaACTIVE MOIETYMNX7R8C5VOCARBIDOPA AND LEVODOPA (CARBIDOPA AND LEVODOPA) TABLET, EXTENDED RELEASE [ETHEX]1
LevodopaACTIVE MOIETY46627O600JCARBIDOPA AND LEVODOPA (CARBIDOPA AND LEVODOPA) TABLET, EXTENDED RELEASE [ETHEX]1
colloidal silicon dioxideINACTIVE INGREDIENTCARBIDOPA AND LEVODOPA (CARBIDOPA AND LEVODOPA) TABLET, EXTENDED RELEASE [ETHEX]1
D&C Yellow No. 10INACTIVE INGREDIENTCARBIDOPA AND LEVODOPA (CARBIDOPA AND LEVODOPA) TABLET, EXTENDED RELEASE [ETHEX]1
FD&C Red No. 3INACTIVE INGREDIENTCARBIDOPA AND LEVODOPA (CARBIDOPA AND LEVODOPA) TABLET, EXTENDED RELEASE [ETHEX]1
fumaric acidINACTIVE INGREDIENT88XHZ13131CARBIDOPA AND LEVODOPA (CARBIDOPA AND LEVODOPA) TABLET, EXTENDED RELEASE [ETHEX]1
hypromelloseINACTIVE INGREDIENTCARBIDOPA AND LEVODOPA (CARBIDOPA AND LEVODOPA) TABLET, EXTENDED RELEASE [ETHEX]1
sodium stearyl fumarateINACTIVE INGREDIENTCARBIDOPA AND LEVODOPA (CARBIDOPA AND LEVODOPA) TABLET, EXTENDED RELEASE [ETHEX]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carbidopa and LevodopaCARBIDOPA AND LEVODOPABryant Ranch Prepack3b06a0e2-bec8-4178-942b-67eb47f2916e2026-07-16Warnings, Adverse reactionsExact identifier
rxcui: 308989
Carbidopa and LevodopaCARBIDOPA AND LEVODOPARadha Pharmaceuticals Inc33a22ffe-0d41-162d-e063-6394a90a43d32026-06-22Warnings, Adverse reactionsExact identifier
rxcui: 308989
CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPASun Pharmaceutical Industries, Inc.d2a64f14-f638-49d9-8a96-cb7ae46ac3ea2026-06-04Warnings, Adverse reactionsExact identifier
rxcui: 308989
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAScieGen Pharmaceuticals Inc1b17ab1e-f3c1-4343-ba28-e2901cd97d432026-06-01Warnings, Adverse reactionsExact identifier
rxcui: 308989
Carbidopa and levodopaCARBIDOPA AND LEVODOPAAdvagen Pharma Ltd5b6519ff-d1af-402b-83eb-b4fce6743a182026-05-12Warnings, Adverse reactionsExact identifier
rxcui: 308989
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAMylan Pharmaceuticals Inc.aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a2026-04-24Warnings, Adverse reactionsExact identifier
rxcui: 308989
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAAlembic Pharmaceuticals Inc.ac18e5fa-e2ee-4aa5-8d0f-94b63a076e662026-03-30Warnings, Adverse reactionsExact identifier
rxcui: 308989
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAAmneal Pharmaceuticals NY LLC0eb24333-3c11-41dd-888d-3a30d3c9d1882026-03-30Warnings, Adverse reactionsExact identifier
rxcui: 308989
Carbidopa and LevodopaCARBIDOPA AND LEVODOPASafecor Health, LLC015bc056-ee86-4006-ae7c-689b95e566f42026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 308989
CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPAAccord Healthcare, Inc.5217a6ec-cc26-4acc-b2da-17f6545c3b602025-10-08Warnings, Adverse reactionsExact identifier
rxcui: 308989
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAMylan Institutional Inc.16f9e4d1-6953-4d4f-b4cf-ad95a856ac252025-07-18Warnings, Adverse reactionsExact identifier
rxcui: 308989
Carbidopa and LevodopaCARBIDOPA AND LEVODOPANCS HealthCare of KY, LLC dba Vangard Labsef0be743-e6f3-4662-8b0c-53f1eda4638a2024-09-13Warnings, Adverse reactionsExact identifier
rxcui: 308989
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAAlembic Pharmaceuticals Limiteda85a56c5-44dd-41d4-ac1c-bdc4758406a42019-06-06Warnings, Adverse reactionsExact identifier
rxcui: 308989
2BA9B4E4-BB60-7672-1E5E-06103D493F632f3b8f28-b3da-4658-bdc4-fe86dec62d322007-08-15Warnings, Adverse reactionsExact identifier
spl id: 2BA9B4E4-BB60-7672-1E5E-06103D493F63
spl set id: 2f3b8f28-b3da-4658-bdc4-fe86dec62d32

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.