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 61 of 130 · 2,582 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Mist SPF-50TITANIUM DIOXIDE, ZINC OXIDETUBBY TODDdca54a19-af25-ce47-e053-2a95a90a22db2025-12-07WarningsExact identifier
unii: 15FIX9V2JP
Solbar Shield SPF40SOLBAR SHIELD SPF40Person and Coveybd3a9a94-fc87-4127-abf9-29e56ac9ce5d2025-12-04WarningsExact identifier
unii: 15FIX9V2JP
BUDDATE INONOTUS OBLIQUUS WATER BRILLIANCE MASKBUTYLENE GLYCOL, GLYCERIN, INONOTUS OBLIQUUS (MUSHROOM) EXTRACTBUDDATE Co Ltd464988ad-557e-13f5-e054-00144ff8d46c2025-11-30WarningsExact identifier
unii: PDC6A3C0OX
BUDDATE LOTUS MOISTURE ESSENCEGLYCERIN, NIACINAMIDE, NELUMBO NUCIFERA FLOWER EXTRACT, PORTULACA OLERACEA EXTRACTBUDDATE Co Ltd46499995-8b13-3e5c-e054-00144ff88e882025-11-30WarningsExact identifier
unii: PDC6A3C0OX
Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDETHG Beauty USA LLC44952d01-7f38-0a9c-e063-6394a90a20182025-11-27WarningsExact identifier
unii: 15FIX9V2JP
salmon colored sunscreenSALMON COLORED SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd4477964b-28f3-a371-e063-6294a90a42302025-11-25WarningsExact identifier
unii: 15FIX9V2JP
it cosmetics Bye Bye Foundation Full Coverage Moisturizer with 3D Skin Flex Broad Spectrum SPF 50 Plus UVA UVB Physical Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA, Inc.86eea4df-4191-4e05-9f05-4a98ef8c2a4d2025-11-24WarningsExact identifier
unii: 15FIX9V2JP
Cetaphil Sun Tinted Face SPF 40TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.22413f93-7219-4726-b741-2392e576b34a2025-11-24WarningsExact identifier
unii: 15FIX9V2JP
VEIL MINERAL PRIMER SUNSCREEN BROAD SPECTRUM SPF 15ZINC OXIDE AND TITANIUM DIOXIDEKingdom Animalia, LLC DBA Hourglass Cosmetics28e23498-953f-47c0-838c-bbf0e858d9032025-11-24WarningsExact identifier
unii: 15FIX9V2JP
Rain Daily Hydration and Comfort For Dry EyesGLYCERINRain Eye Drops, LLC31d7c204-fb74-fb28-e063-6294a90ab3302025-11-23WarningsExact identifier
unii: PDC6A3C0OX
SULWHASOO PERFECTING CUSHION NO. 25OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEAmorepacific Corporation8d420e4b-c778-3ed4-e053-2995a90a59a92025-11-20WarningsExact identifier
unii: 15FIX9V2JP
Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDENorwex Usa, Inc.f527a8c5-b05e-5f3c-e053-2995a90aa1a32025-11-20WarningsExact identifier
unii: 15FIX9V2JP
Sandra Plasencia Green Tea Daily SPF 50 MoisturizerTITANIUM DIOXIDESandra Plasencia Skincare43ef1f93-0e89-0a35-e063-6394a90afb512025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Brain LiquescenceGINKGO BILOBA, COLCHICUM AUTUMNALE, CONVALLARIA MAJALIS, NUX MOSCHATA, CEREBRUM (SUIS), AGARICUS MUSCARIUS, SCUTELLARIA LATERIFLORA, ANACARDIUM ORIENTALE, RIBOFLAVINUM, AMBRA GRISEA, BARYTA CARBONICA, GLYCERINUMNutritional Specialties, Inc.a5c366f3-fd42-4602-b20b-b7b15fde564e2025-11-19WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc804d7b1f-1be8-50c9-e053-2a91aa0a35d02025-11-18WarningsExact identifier
unii: PDC6A3C0OX
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 17NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c48c66-bd5b-0024-e063-6394a90a6c7b2025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 19COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c512da-e4b6-dd9c-e063-6294a90a17302025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c52258-2549-c42b-e063-6394a90a15262025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c59de6-8eb2-d00a-e063-6294a90a0b042025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 24WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c5bd02-62e0-019a-e063-6294a90adcf32025-11-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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