FDA.reportPublic FDA data

Carbidopa and Levodopa

Product NDC
51079-978
11-digit product format
510790978
Labeler code
51079
Product ID
51079-978_3a39bb13-44d1-2652-e063-6294a90ad211
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbidopa and levodopa
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA075091
Marketing category
ANDA
Marketing start
2002-02-01
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
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
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
51079-978-01Carbidopa and Levodopa1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE113
51079-978-20Carbidopa and Levodopa100 in 1 CARTONTABLET, EXTENDED RELEASE10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-978-01EA - Each51079-9783e94a9f3-e399-4ed4-a90a-f21d340ece5d12012-07-24
51079-978-20EA - Each51079-978af6db609-0fc4-485e-87b0-373993a257e112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
51079-978CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]12Current NDC, Legacy NDC, 2 package rows20240104_16f9e4d1-6953-4d4f-b4cf-ad95a856ac25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-978-01510790978011 in 1 BLISTER PACKHistorical
51079-978-2051079097820100 BLISTER PACK in 1 CARTON (51079-978-20) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51079-978-01) 100 blister pack2002-02-010000-00-00NoNoCurrent