FDA.reportPublic FDA data

Carbidopa and Levodopa

Product NDC
0378-0088
11-digit product format
003780088
Labeler code
0378
Product ID
0378-0088_164375a9-db50-4cb3-86ca-a52a3e74cc83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbidopa and levodopa
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA075091
Marketing category
ANDA
Marketing start
2000-04-26
Substance
CARBIDOPA; LEVODOPA
Active strength
25; 100 mg/1; mg/1
Pharmacologic classes
Amino Acids, Aromatic [CS], Aromatic Amino Acid [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 and Levodopa
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBIDOPA25 mg/1
LEVODOPA100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii46627O600J, MNX7R8C5VO
Rxcui308988, 308989

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-0088-01Carbidopa and Levodopa100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0088-01EA - Each0378-008829ecee5f-af93-4575-ad1f-d5fb0775e52812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBIDOPAACTIVE INGREDIENTMNX7R8C5VOCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
LEVODOPAACTIVE INGREDIENT46627O600JCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
CARBIDOPA ANHYDROUSACTIVE MOIETYKR87B45RGHCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
LEVODOPAACTIVE MOIETY46627O600JCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
CARBIDOPAACTIVE INGREDIENTMNX7R8C5VOCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]4
LEVODOPAACTIVE INGREDIENT46627O600JCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]4
CARBIDOPA ANHYDROUSACTIVE MOIETYKR87B45RGHCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]4
LEVODOPAACTIVE MOIETY46627O600JCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0088CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]13Current NDC, Legacy NDC, 1 package rows20221229_aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletPSNaa5028d6-fd0a-4cf1-b708-c93bb2a7c76a15
308989carbidopa 50 MG / levodopa 200 MG Extended Release Oral TabletPSNaa5028d6-fd0a-4cf1-b708-c93bb2a7c76a15
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletSCDaa5028d6-fd0a-4cf1-b708-c93bb2a7c76a15
308989carbidopa 50 MG / levodopa 200 MG Extended Release Oral TabletSCDaa5028d6-fd0a-4cf1-b708-c93bb2a7c76a15
308988carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Extended Release Oral TabletSYaa5028d6-fd0a-4cf1-b708-c93bb2a7c76a15
308989carbidopa (as carbidopa monohydrate) 50 MG / levodopa 200 MG Extended Release Oral TabletSYaa5028d6-fd0a-4cf1-b708-c93bb2a7c76a15
308988Carbidopa 25 MG / L-DOPA 100 MG Extended Release Oral TabletSYaa5028d6-fd0a-4cf1-b708-c93bb2a7c76a15
308989Carbidopa 50 MG / L-DOPA 200 MG Extended Release Oral TabletSYaa5028d6-fd0a-4cf1-b708-c93bb2a7c76a15
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletPSN16f9e4d1-6953-4d4f-b4cf-ad95a856ac2513
308989carbidopa 50 MG / levodopa 200 MG Extended Release Oral TabletPSN16f9e4d1-6953-4d4f-b4cf-ad95a856ac2513
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletSCD16f9e4d1-6953-4d4f-b4cf-ad95a856ac2513
308989carbidopa 50 MG / levodopa 200 MG Extended Release Oral TabletSCD16f9e4d1-6953-4d4f-b4cf-ad95a856ac2513
308988carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Extended Release Oral TabletSY16f9e4d1-6953-4d4f-b4cf-ad95a856ac2513
308989carbidopa (as carbidopa monohydrate) 50 MG / levodopa 200 MG Extended Release Oral TabletSY16f9e4d1-6953-4d4f-b4cf-ad95a856ac2513
308988Carbidopa 25 MG / L-DOPA 100 MG Extended Release Oral TabletSY16f9e4d1-6953-4d4f-b4cf-ad95a856ac2513
308989Carbidopa 50 MG / L-DOPA 200 MG Extended Release Oral TabletSY16f9e4d1-6953-4d4f-b4cf-ad95a856ac2513
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletPSN8dda2a01-637b-4bf6-9c5d-00a77870be022
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletPSN015bc056-ee86-4006-ae7c-689b95e566f42
308989carbidopa 50 MG / levodopa 200 MG Extended Release Oral TabletPSN015bc056-ee86-4006-ae7c-689b95e566f42
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletSCD8dda2a01-637b-4bf6-9c5d-00a77870be022
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletSCD015bc056-ee86-4006-ae7c-689b95e566f42
308989carbidopa 50 MG / levodopa 200 MG Extended Release Oral TabletSCD015bc056-ee86-4006-ae7c-689b95e566f42
308988carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Extended Release Oral TabletSY8dda2a01-637b-4bf6-9c5d-00a77870be022
308988carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Extended Release Oral TabletSY015bc056-ee86-4006-ae7c-689b95e566f42
308989carbidopa (as carbidopa monohydrate) 50 MG / levodopa 200 MG Extended Release Oral TabletSY015bc056-ee86-4006-ae7c-689b95e566f42
308988Carbidopa 25 MG / L-DOPA 100 MG Extended Release Oral TabletSY8dda2a01-637b-4bf6-9c5d-00a77870be022
308988Carbidopa 25 MG / L-DOPA 100 MG Extended Release Oral TabletSY015bc056-ee86-4006-ae7c-689b95e566f42
308989Carbidopa 50 MG / L-DOPA 200 MG Extended Release Oral TabletSY015bc056-ee86-4006-ae7c-689b95e566f42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-0088-0100378008801100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0088-01) 2000-04-260000-00-00NoNoCurrent