FDA.reportPublic FDA data

Carbidopa, levodopa and entacapone

Product NDC
47335-001
11-digit product format
473350001
Labeler code
47335
Product ID
47335-001_8117c8ca-d1f7-4adb-a038-efcd87cb5cd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa, levodopa and entacapone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA021485
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-10-02
Marketing end
0000-00-00
Substance
CARBIDOPA; LEVODOPA; ENTACAPONE
Active strength
13 mg/1; mg/1; mg/1
Pharmacologic classes
Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ce6fab2-d006-4589-8ba0-02cee499cc60Product name220260128
ebf3b793-6fcd-797b-9d2e-c3faf6d29442Product name520251106
162160fe-5ea6-4f9d-aa38-c4b780c57046Product name120250515
0e5ae331-9620-4d1f-8061-7c437c7f1c42Product name120250312
028fdaca-77da-0dfe-e445-7dfc440fc97eProduct name420250224
7d015b89-35e8-b484-e5db-c0c44814f63cProduct name720241218
6a098371-84f5-7ced-0ac5-ed90d535b476Product name620220927
de702a02-e9c0-4daf-9101-e44f2c0d4e66Product name120220609
681917df-580c-4199-896d-b739fbb25ed3Product name120190412
7d015b89-35e8-b484-e5db-c0c44814f63cProduct name420171212
1fa100ae-9ab3-4df0-afe7-33ab01fd4a41Product name120150313
88839c8d-b65b-4a50-997b-4c74539855ffProduct name120150313

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47335-001-882021-01-29C16284748780-1ba0f9c33-42ff-a910-e053-dadaa90a0b85These 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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-001-88Carbidopa, levodopa and entacapone100 in 1 BOTTLETABLET, FILM COATED1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-001-88EA - Each47335-00144e246e9-b4e2-442d-a735-68dd6eb60e9112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBIDOPAACTIVE INGREDIENTMNX7R8C5VOCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
ENTACAPONEACTIVE INGREDIENT4975G9NM6TCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
LEVODOPAACTIVE INGREDIENT46627O600JCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
CARBIDOPA ANHYDROUSACTIVE MOIETYKR87B45RGHCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
ENTACAPONEACTIVE MOIETY4975G9NM6TCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
LEVODOPAACTIVE MOIETY46627O600JCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
MANNITOLINACTIVE INGREDIENT3OWL53L36ACARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
POVIDONEINACTIVE INGREDIENTFZ989GH94ECARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
SUCROSEINACTIVE INGREDIENTC151H8M554CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-001CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]8Legacy NDC, 1 package rows20190302_967bd870-7517-43bc-90eb-05e831d688ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403850carbidopa 12.5 MG / levodopa 50 MG / entacapone 200 MG Oral TabletPSN967bd870-7517-43bc-90eb-05e831d688ae8
810090carbidopa 18.75 MG / levodopa 75 MG / entacapone 200 MG Oral TabletPSN967bd870-7517-43bc-90eb-05e831d688ae8
403851carbidopa 25 MG / levodopa 100 MG / entacapone 200 MG Oral TabletPSN967bd870-7517-43bc-90eb-05e831d688ae8
810083carbidopa 31.25 MG / levodopa 125 MG / entacapone 200 MG Oral TabletPSN967bd870-7517-43bc-90eb-05e831d688ae8
403852carbidopa 37.5 MG / levodopa 150 MG / entacapone 200 MG Oral TabletPSN967bd870-7517-43bc-90eb-05e831d688ae8
730988carbidopa 50 MG / levodopa 200 MG / entacapone 200 MG Oral TabletPSN967bd870-7517-43bc-90eb-05e831d688ae8
403850carbidopa 12.5 MG / entacapone 200 MG / levodopa 50 MG Oral TabletSCD967bd870-7517-43bc-90eb-05e831d688ae8
810090carbidopa 18.75 MG / entacapone 200 MG / levodopa 75 MG Oral TabletSCD967bd870-7517-43bc-90eb-05e831d688ae8
403851carbidopa 25 MG / entacapone 200 MG / levodopa 100 MG Oral TabletSCD967bd870-7517-43bc-90eb-05e831d688ae8
810083carbidopa 31.25 MG / entacapone 200 MG / levodopa 125 MG Oral TabletSCD967bd870-7517-43bc-90eb-05e831d688ae8
403852carbidopa 37.5 MG / entacapone 200 MG / levodopa 150 MG Oral TabletSCD967bd870-7517-43bc-90eb-05e831d688ae8
730988carbidopa 50 MG / entacapone 200 MG / levodopa 200 MG Oral TabletSCD967bd870-7517-43bc-90eb-05e831d688ae8
403850Carbidopa 12.5 MG / entacapone 200 MG / L-DOPA 50 MG Oral TabletSY967bd870-7517-43bc-90eb-05e831d688ae8
810090Carbidopa 18.75 MG / entacapone 200 MG / L-DOPA 75 MG Oral TabletSY967bd870-7517-43bc-90eb-05e831d688ae8
403851Carbidopa 25 MG / entacapone 200 MG / L-DOPA 100 MG Oral TabletSY967bd870-7517-43bc-90eb-05e831d688ae8
810083Carbidopa 31.25 MG / entacapone 200 MG / L-DOPA 125 MG Oral TabletSY967bd870-7517-43bc-90eb-05e831d688ae8
403852Carbidopa 37.5 MG / entacapone 200 MG / L-DOPA 150 MG Oral TabletSY967bd870-7517-43bc-90eb-05e831d688ae8
730988Carbidopa 50 MG / entacapone 200 MG / L-DOPA 200 MG Oral TabletSY967bd870-7517-43bc-90eb-05e831d688ae8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
47335-001-8847335000188100 in 1 BOTTLEHistorical