FDA.reportPublic FDA data

NDC 64679-784-02 - CARBIDOPA, LEVODOPA AND ENTACAPONE

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
64679-784
Requested NDC
64679-784-02
Package NDCs from labels
64679-784-04, 64679-784-02
Manufacturer
Wockhardt USA LLC. | Orion Corporation, Orion Pharma
Effective date
2020-12-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LEVODOPA - Wockhardt USA LLC. | Orion Corporation, Orion PharmaWockhardt USA LLC. | Orion Corporation, Orion Pharma2020-12-23HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64679-784-042020-02-21C16284748780-19d75b9d0-bc89-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use carbidopa, levodopa and entacapone tablets safely and effectively. See full prescribing information for carbidopa, levodopa and entacapone tablets. Carbidopa, Levodopa and Entacapone tablets, for oral use Initial U.S. Approval:2003
64679-784-042020-01-31C16284748780-19d75b9d0-bc89-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use carbidopa, levodopa and entacapone tablets safely and effectively. See full prescribing information for carbidopa, levodopa and entacapone tablets. Carbidopa, Levodopa and Entacapone tablets, for oral use Initial U.S. Approval:2003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-784-02EA - Each64679-7849acd207e-2521-481c-b60a-5b616c517c2212013-02-13
64679-784-04EA - Each64679-784f541a5e7-2468-4030-b17b-65339d116c9c12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBIDOPAACTIVE INGREDIENTMNX7R8C5VOCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]4
ENTACAPONEACTIVE INGREDIENT4975G9NM6TCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]4
LEVODOPAACTIVE INGREDIENT46627O600JCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]4
CARBIDOPA ANHYDROUSACTIVE MOIETYKR87B45RGHCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]4
ENTACAPONEACTIVE MOIETY4975G9NM6TCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]4
LEVODOPAACTIVE MOIETY46627O600JCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]4
MANNITOLINACTIVE INGREDIENT3OWL53L36ACARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]4
POVIDONEINACTIVE INGREDIENTFZ989GH94ECARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.]4

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 19 of 131 · 2,612 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermatool HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPapalo Group LLC4bc06f41-7733-ebd0-e063-6294a90af7a82026-02-26WarningsExact identifier
unii: PDC6A3C0OX
SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORYOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONc05cef12-a6a7-4682-9357-6d77f4ca32672026-02-25WarningsExact identifier
unii: 15FIX9V2JP
cle de peau BEAUTE RADIANT FOUNDATION N M I10OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation3be1fe06-bd3b-4078-bee9-d3caf8d068ff2026-02-25WarningsExact identifier
unii: 15FIX9V2JP
cle de peau BEAUTE THE FOUNDATION N M O20OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation9507f6d1-c11c-428d-8d95-b436f27ba26a2026-02-24WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDFamily Dollar Stores, Inc1a03331e-3676-451c-be22-9a547e8ae6e22026-02-24Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b93538a-3b3e-90f7-e063-6294a90ab8982026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b93cd22-1289-29bc-e063-6294a90ab7812026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b943d72-dcde-e2e4-e063-6294a90ab7c42026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING NON-TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b946c39-718b-d70e-e063-6394a90a0db82026-02-24WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEShiseido Americas Corporationb93f10dc-193d-4cda-94b6-3f0e54d89f212026-02-23WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO ULTIMATE SUN PROTECTOR MINERALTITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION5e31eee8-6532-47ea-99fc-22418791804b2026-02-23WarningsExact identifier
unii: 15FIX9V2JP
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b47e7cb-17d6-6a7c-e063-6294a90abbea2026-02-20WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDPerrigo Direct, Inc256bd1d4-fd50-408f-9aee-84f218bb49712026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXIND HCLPerrigo Direct, Inc54a20ec9-ab86-4410-af94-e04393e9d4b32026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLMeijer, Inc.6b369ef2-fd54-4931-a9eb-0fb42834c2ef2026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42TITANIUM DIOXIDE, ZINC OXIDEALLAY SKIN SOLUTIONS LLC425bf1d7-f2cf-4237-9047-dd53054acd1c2026-02-18WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDTarget Corporationd4ee05c8-ae62-45df-8783-1ed57fa030ec2026-02-18Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARINTITANIUM DIOXIDES.A. COMPTOIR NOUVEAU DE LA PARFUMERIEdacff3dc-49d7-6416-e053-2a95a90a85c62026-02-18WarningsExact identifier
unii: 15FIX9V2JP
carbidopa, levodopa and entacaponeCARBIDOPA, LEVODOPA AND ENTACAPONEAlembic Pharmaceuticals Limited9ff83838-b7d0-4eec-98f2-fcc85789a1892026-02-17Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 4975G9NM6T
unii: 46627O600J
EntacaponeENTACAPONERising Pharma Holdings, Inc.ee02a04a-4b42-4cfa-8d9d-b1459c0ee9fd2026-02-16Warnings, Adverse reactionsExact identifier
unii: 4975G9NM6T

Reported adverse events (FAERS/openFDA)#

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