FDA.reportPublic FDA data

Carbidopa and Levodopa

Product NDC
59651-456
11-digit product format
596510456
Labeler code
59651
Product ID
59651-456_7a87848d-1fcb-4df6-ac7c-b506cc8dc95a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA216537
Marketing category
ANDA
Marketing start
2022-11-28
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
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
CARBIDOPA10 mg/1
LEVODOPA100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii46627O600J, MNX7R8C5VO
Rxcui197443, 197444, 197445

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
59651-456-01Carbidopa and Levodopa100 in 1 BOTTLETABLET1003
59651-456-05Carbidopa and Levodopa500 in 1 BOTTLETABLET5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-456-01EA - Each59651-456e787aeb1-40ab-4eed-9539-aae6a86bbd7312023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-456CARBIDOPA AND LEVODOPA TABLET [AUROBINDO PHARMA LIMITED]2Current NDC, Legacy NDC, 2 package rows20221214_4ced8a05-27ac-463f-b331-387e473fdaa1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197443carbidopa 10 MG / levodopa 100 MG Oral TabletPSN4ced8a05-27ac-463f-b331-387e473fdaa13
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN4ced8a05-27ac-463f-b331-387e473fdaa13
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSN4ced8a05-27ac-463f-b331-387e473fdaa13
197443carbidopa 10 MG / levodopa 100 MG Oral TabletSCD4ced8a05-27ac-463f-b331-387e473fdaa13
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD4ced8a05-27ac-463f-b331-387e473fdaa13
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCD4ced8a05-27ac-463f-b331-387e473fdaa13
197443carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral TabletSY4ced8a05-27ac-463f-b331-387e473fdaa13
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY4ced8a05-27ac-463f-b331-387e473fdaa13
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSY4ced8a05-27ac-463f-b331-387e473fdaa13
197443Carbidopa 10 MG / L-DOPA 100 MG Oral TabletSY4ced8a05-27ac-463f-b331-387e473fdaa13
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY4ced8a05-27ac-463f-b331-387e473fdaa13
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSY4ced8a05-27ac-463f-b331-387e473fdaa13
197443carbidopa 10 MG / levodopa 100 MG Oral TabletPSN43ce5061-0830-6f4f-e063-6394a90afc591
197443carbidopa 10 MG / levodopa 100 MG Oral TabletSCD43ce5061-0830-6f4f-e063-6394a90afc591
197443carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral TabletSY43ce5061-0830-6f4f-e063-6394a90afc591
197443Carbidopa 10 MG / L-DOPA 100 MG Oral TabletSY43ce5061-0830-6f4f-e063-6394a90afc591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-456-0159651045601100 TABLET in 1 BOTTLE (59651-456-01) 100 tablet2022-11-280000-00-00NoNoCurrent
59651-456-0559651045605500 TABLET in 1 BOTTLE (59651-456-05) 500 tablet2022-11-280000-00-00NoNoCurrent