FDA.reportPublic FDA data

Carbidopa and Levodopa

Product NDC
0378-0078
11-digit product format
003780078
Labeler code
0378
Product ID
0378-0078_26fe1be4-3d62-438c-a3d3-21999097cbae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbidopa and levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA090324
Marketing category
ANDA
Marketing start
2011-05-16
Marketing end
0000-00-00
Substance
CARBIDOPA; LEVODOPA
Active strength
10 mg/1; mg/1
Pharmacologic classes
Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0078-01EA - Each0378-0078206cde3c-5970-4bde-9cc0-f5584831d29b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBIDOPAACTIVE INGREDIENTMNX7R8C5VOCARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]5
LEVODOPAACTIVE INGREDIENT46627O600JCARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]5
CARBIDOPA ANHYDROUSACTIVE MOIETYKR87B45RGHCARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]5
LEVODOPAACTIVE MOIETY46627O600JCARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0078CARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]11Legacy NDC20250101_3c768639-8a70-4d12-ad93-827bb42ec6b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197443carbidopa 10 MG / levodopa 100 MG Oral TabletPSNa7e669fc-c011-4e51-85e6-b68d4e4738a82
197443carbidopa 10 MG / levodopa 100 MG Oral TabletSCDa7e669fc-c011-4e51-85e6-b68d4e4738a82
197443carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral TabletSYa7e669fc-c011-4e51-85e6-b68d4e4738a82
197443Carbidopa 10 MG / L-DOPA 100 MG Oral TabletSYa7e669fc-c011-4e51-85e6-b68d4e4738a82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-0078-0100378007801100 TABLET in 1 BOTTLE, PLASTIC (0378-0078-01) 100 tablet2011-05-160000-00-00NoNoCurrent