FDA.reportPublic FDA data

Carbidopa, Levodopa, and Entacapone

Product NDC
0781-5625
11-digit product format
007815625
Labeler code
0781
Product ID
0781-5625_2176ea25-da6b-47b2-a081-b3da614df0a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa, Levodopa, and Entacapone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
NDA021485
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-06-18
Substance
CARBIDOPA; ENTACAPONE; LEVODOPA
Active strength
18.75; 200; 75 mg/1; mg/1; mg/1
Pharmacologic classes
Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Carbidopa, Levodopa, and Entacapone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBIDOPA18.75 mg/1
ENTACAPONE200 mg/1
LEVODOPA75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii46627O600J, 4975G9NM6T, MNX7R8C5VO
Rxcui403850, 403851, 403852, 730988, 810083, 810090

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-5625-01Carbidopa, Levodopa, and Entacapone100 in 1 BOTTLETABLET, FILM COATED10014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5625-01EA - Each0781-5625736f2090-d86b-4338-84c0-434d8945181c12014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBIDOPAACTIVE INGREDIENTMNX7R8C5VOCARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC]10
ENTACAPONEACTIVE INGREDIENT4975G9NM6TCARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC]10
LEVODOPAACTIVE INGREDIENT46627O600JCARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC]10
CARBIDOPA ANHYDROUSACTIVE MOIETYKR87B45RGHCARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC]10
ENTACAPONEACTIVE MOIETY4975G9NM6TCARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC]10
LEVODOPAACTIVE MOIETY46627O600JCARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC]10
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC]10
MANNITOLINACTIVE INGREDIENT3OWL53L36ACARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC]10
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC]10
POVIDONESINACTIVE INGREDIENTFZ989GH94ECARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC]10
SUCROSEINACTIVE INGREDIENTC151H8M554CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-5625CARBIDOPA, LEVODOPA, AND ENTACAPONE TABLET, FILM COATED [SANDOZ INC]13Current NDC, Legacy NDC, 1 package rows20250507_9c16c0e0-3b97-486b-b7d5-579f5853e2c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403850carbidopa 12.5 MG / levodopa 50 MG / entacapone 200 MG Oral TabletPSN9c16c0e0-3b97-486b-b7d5-579f5853e2c514
810090carbidopa 18.75 MG / levodopa 75 MG / entacapone 200 MG Oral TabletPSN9c16c0e0-3b97-486b-b7d5-579f5853e2c514
403851carbidopa 25 MG / levodopa 100 MG / entacapone 200 MG Oral TabletPSN9c16c0e0-3b97-486b-b7d5-579f5853e2c514
810083carbidopa 31.25 MG / levodopa 125 MG / entacapone 200 MG Oral TabletPSN9c16c0e0-3b97-486b-b7d5-579f5853e2c514
403852carbidopa 37.5 MG / levodopa 150 MG / entacapone 200 MG Oral TabletPSN9c16c0e0-3b97-486b-b7d5-579f5853e2c514
730988carbidopa 50 MG / levodopa 200 MG / entacapone 200 MG Oral TabletPSN9c16c0e0-3b97-486b-b7d5-579f5853e2c514
403850carbidopa 12.5 MG / entacapone 200 MG / levodopa 50 MG Oral TabletSCD9c16c0e0-3b97-486b-b7d5-579f5853e2c514
810090carbidopa 18.75 MG / entacapone 200 MG / levodopa 75 MG Oral TabletSCD9c16c0e0-3b97-486b-b7d5-579f5853e2c514
403851carbidopa 25 MG / entacapone 200 MG / levodopa 100 MG Oral TabletSCD9c16c0e0-3b97-486b-b7d5-579f5853e2c514
810083carbidopa 31.25 MG / entacapone 200 MG / levodopa 125 MG Oral TabletSCD9c16c0e0-3b97-486b-b7d5-579f5853e2c514
403852carbidopa 37.5 MG / entacapone 200 MG / levodopa 150 MG Oral TabletSCD9c16c0e0-3b97-486b-b7d5-579f5853e2c514
730988carbidopa 50 MG / entacapone 200 MG / levodopa 200 MG Oral TabletSCD9c16c0e0-3b97-486b-b7d5-579f5853e2c514
403850Carbidopa 12.5 MG / entacapone 200 MG / L-DOPA 50 MG Oral TabletSY9c16c0e0-3b97-486b-b7d5-579f5853e2c514
810090Carbidopa 18.75 MG / entacapone 200 MG / L-DOPA 75 MG Oral TabletSY9c16c0e0-3b97-486b-b7d5-579f5853e2c514
403851Carbidopa 25 MG / entacapone 200 MG / L-DOPA 100 MG Oral TabletSY9c16c0e0-3b97-486b-b7d5-579f5853e2c514
810083Carbidopa 31.25 MG / entacapone 200 MG / L-DOPA 125 MG Oral TabletSY9c16c0e0-3b97-486b-b7d5-579f5853e2c514
403852Carbidopa 37.5 MG / entacapone 200 MG / L-DOPA 150 MG Oral TabletSY9c16c0e0-3b97-486b-b7d5-579f5853e2c514
730988Carbidopa 50 MG / entacapone 200 MG / L-DOPA 200 MG Oral TabletSY9c16c0e0-3b97-486b-b7d5-579f5853e2c514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-5625-0100781562501100 TABLET, FILM COATED in 1 BOTTLE (0781-5625-01) 2014-06-180000-00-00NoNoCurrent