FDA.reportPublic FDA data

carbidopa, levodopa and entacapone

Product NDC
55648-786
11-digit product format
556480786
Labeler code
55648
Product ID
55648-786_9866a9f3-77fb-43ec-b516-2a4dac01e1cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbidopa, levodopa and entacapone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wockhardt Limited
Application
NDA021485
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-02-29
Marketing end
0000-00-00
Substance
CARBIDOPA; ENTACAPONE; LEVODOPA
Active strength
38 mg/1; mg/1; mg/1
Pharmacologic classes
Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
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
55648-786-022020-01-31C16284748780-19d75b9d0-2c26-f424-e053-dadaa90a57ceCarbidopa, Levodopa and Entacapone Tablets
55648-786-032020-01-31C16284748780-19d75b9d0-2c26-f424-e053-dadaa90a57ceCarbidopa, Levodopa and Entacapone Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-786-02carbidopa, levodopa and entacapone100 in 1 BOTTLETABLET, FILM COATED1003
55648-786-03carbidopa, levodopa and entacapone500 in 1 BOTTLETABLET, FILM COATED5003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBIDOPAACTIVE INGREDIENTMNX7R8C5VOCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]3
ENTACAPONEACTIVE INGREDIENT4975G9NM6TCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]3
LEVODOPAACTIVE INGREDIENT46627O600JCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]3
CARBIDOPAACTIVE MOIETYMNX7R8C5VOCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]3
ENTACAPONEACTIVE MOIETY4975G9NM6TCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]3
LEVODOPAACTIVE MOIETY46627O600JCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ACARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ECARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]3
SUCROSEINACTIVE INGREDIENTC151H8M554CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-786CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]3Legacy NDC, 2 package rows20120530_dabb7f5d-03b3-4d46-951a-e41a1f8d69cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403850carbidopa 12.5 MG / levodopa 50 MG / entacapone 200 MG Oral TabletPSNdabb7f5d-03b3-4d46-951a-e41a1f8d69cc3
810090carbidopa 18.75 MG / levodopa 75 MG / entacapone 200 MG Oral TabletPSNdabb7f5d-03b3-4d46-951a-e41a1f8d69cc3
403851carbidopa 25 MG / levodopa 100 MG / entacapone 200 MG Oral TabletPSNdabb7f5d-03b3-4d46-951a-e41a1f8d69cc3
810083carbidopa 31.25 MG / levodopa 125 MG / entacapone 200 MG Oral TabletPSNdabb7f5d-03b3-4d46-951a-e41a1f8d69cc3
403852carbidopa 37.5 MG / levodopa 150 MG / entacapone 200 MG Oral TabletPSNdabb7f5d-03b3-4d46-951a-e41a1f8d69cc3
730988carbidopa 50 MG / levodopa 200 MG / entacapone 200 MG Oral TabletPSNdabb7f5d-03b3-4d46-951a-e41a1f8d69cc3
403850carbidopa 12.5 MG / entacapone 200 MG / levodopa 50 MG Oral TabletSCDdabb7f5d-03b3-4d46-951a-e41a1f8d69cc3
810090carbidopa 18.75 MG / entacapone 200 MG / levodopa 75 MG Oral TabletSCDdabb7f5d-03b3-4d46-951a-e41a1f8d69cc3
403851carbidopa 25 MG / entacapone 200 MG / levodopa 100 MG Oral TabletSCDdabb7f5d-03b3-4d46-951a-e41a1f8d69cc3
810083carbidopa 31.25 MG / entacapone 200 MG / levodopa 125 MG Oral TabletSCDdabb7f5d-03b3-4d46-951a-e41a1f8d69cc3
403852carbidopa 37.5 MG / entacapone 200 MG / levodopa 150 MG Oral TabletSCDdabb7f5d-03b3-4d46-951a-e41a1f8d69cc3
730988carbidopa 50 MG / entacapone 200 MG / levodopa 200 MG Oral TabletSCDdabb7f5d-03b3-4d46-951a-e41a1f8d69cc3
403850Carbidopa 12.5 MG / entacapone 200 MG / L-DOPA 50 MG Oral TabletSYdabb7f5d-03b3-4d46-951a-e41a1f8d69cc3
810090Carbidopa 18.75 MG / entacapone 200 MG / L-DOPA 75 MG Oral TabletSYdabb7f5d-03b3-4d46-951a-e41a1f8d69cc3
403851Carbidopa 25 MG / entacapone 200 MG / L-DOPA 100 MG Oral TabletSYdabb7f5d-03b3-4d46-951a-e41a1f8d69cc3
810083Carbidopa 31.25 MG / entacapone 200 MG / L-DOPA 125 MG Oral TabletSYdabb7f5d-03b3-4d46-951a-e41a1f8d69cc3
403852Carbidopa 37.5 MG / entacapone 200 MG / L-DOPA 150 MG Oral TabletSYdabb7f5d-03b3-4d46-951a-e41a1f8d69cc3
730988Carbidopa 50 MG / entacapone 200 MG / L-DOPA 200 MG Oral TabletSYdabb7f5d-03b3-4d46-951a-e41a1f8d69cc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-786-0255648078602100 in 1 BOTTLEHistorical
55648-786-0355648078603500 in 1 BOTTLEHistorical