FDA.reportPublic FDA data

CARBIDOPA AND LEVODOPA

Product NDC
47335-186
11-digit product format
473350186
Labeler code
47335
Product ID
47335-186_5c297458-6e97-4222-8a82-1b28928ce796
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBIDOPA AND LEVODOPA
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA078690
Marketing category
ANDA
Marketing start
2014-12-15
Substance
CARBIDOPA; LEVODOPA
Active strength
10; 100 mg/1; mg/1
Pharmacologic classes
Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CARBIDOPA AND LEVODOPA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBIDOPA10 mg/1
LEVODOPA100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMNX7R8C5VO, 46627O600J
Rxcui476399, 476515, 483090

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
de702a02-e9c0-4daf-9101-e44f2c0d4e66Product name120220609
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
681917df-580c-4199-896d-b739fbb25ed3Product name120190412
7d015b89-35e8-b484-e5db-c0c44814f63cProduct name420171212
1fa100ae-9ab3-4df0-afe7-33ab01fd4a41Product name120150313
88839c8d-b65b-4a50-997b-4c74539855ffProduct name120150313
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-186-08CARBIDOPA AND LEVODOPA100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1008
47335-186-18CARBIDOPA AND LEVODOPA1000 in 1 BOTTLETABLET, ORALLY DISINTEGRATING10008
47335-186-83CARBIDOPA AND LEVODOPA30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING308
47335-186-88CARBIDOPA AND LEVODOPA100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-186-88EA - Each47335-18607523cc0-61fc-4da8-aae0-fe3f731b7e8312015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBIDOPAACTIVE INGREDIENTMNX7R8C5VOCARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [SUN PHARMA GLOBAL FZE]2
LEVODOPAACTIVE INGREDIENT46627O600JCARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [SUN PHARMA GLOBAL FZE]2
CARBIDOPA ANHYDROUSACTIVE MOIETYKR87B45RGHCARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [SUN PHARMA GLOBAL FZE]2
LEVODOPAACTIVE MOIETY46627O600JCARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [SUN PHARMA GLOBAL FZE]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [SUN PHARMA GLOBAL FZE]2
CALCIUM SILICATEINACTIVE INGREDIENTS4255P4G5MCARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [SUN PHARMA GLOBAL FZE]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [SUN PHARMA GLOBAL FZE]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [SUN PHARMA GLOBAL FZE]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [SUN PHARMA GLOBAL FZE]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [SUN PHARMA GLOBAL FZE]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [SUN PHARMA GLOBAL FZE]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [SUN PHARMA GLOBAL FZE]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ACARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [SUN PHARMA GLOBAL FZE]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ECARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [SUN PHARMA GLOBAL FZE]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [SUN PHARMA GLOBAL FZE]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [SUN PHARMA GLOBAL FZE]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-186CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES, INC.]8Current NDC, Legacy NDC, 4 package rows20241210_48e0f2ec-b217-4c25-a71c-20e173d05edb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483090carbidopa 10 MG / levodopa 100 MG Disintegrating Oral TabletPSN48e0f2ec-b217-4c25-a71c-20e173d05edb8
476399carbidopa 25 MG / levodopa 100 MG Disintegrating Oral TabletPSN48e0f2ec-b217-4c25-a71c-20e173d05edb8
476515carbidopa 25 MG / levodopa 250 MG Disintegrating Oral TabletPSN48e0f2ec-b217-4c25-a71c-20e173d05edb8
483090carbidopa 10 MG / levodopa 100 MG Disintegrating Oral TabletSCD48e0f2ec-b217-4c25-a71c-20e173d05edb8
476399carbidopa 25 MG / levodopa 100 MG Disintegrating Oral TabletSCD48e0f2ec-b217-4c25-a71c-20e173d05edb8
476515carbidopa 25 MG / levodopa 250 MG Disintegrating Oral TabletSCD48e0f2ec-b217-4c25-a71c-20e173d05edb8
483090Carbidopa 10 MG / L-DOPA 100 MG Disintegrating Oral TabletSY48e0f2ec-b217-4c25-a71c-20e173d05edb8
476399Carbidopa 25 MG / L-DOPA 100 MG Disintegrating Oral TabletSY48e0f2ec-b217-4c25-a71c-20e173d05edb8
476515Carbidopa 25 MG / L-DOPA 250 MG Disintegrating Oral TabletSY48e0f2ec-b217-4c25-a71c-20e173d05edb8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-186-0847335018608100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-186-08) 2014-12-150000-00-00NoNoCurrent
47335-186-18473350186181000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-186-18) 2014-12-150000-00-00NoNoCurrent
47335-186-834733501868330 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-186-83) 2014-12-150000-00-00NoNoCurrent
47335-186-8847335018688100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-186-88) 2014-12-150000-00-00NoNoCurrent