FDA.reportPublic FDA data

Carbidopa and Levodopa

Product NDC
59651-458
11-digit product format
596510458
Labeler code
59651
Product ID
59651-458_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
25; 250 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
LEVODOPA250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMNX7R8C5VO, 46627O600J
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
59651-458-01Carbidopa and Levodopa100 in 1 BOTTLETABLET1003
59651-458-05Carbidopa and Levodopa500 in 1 BOTTLETABLET5003
59651-458-99Carbidopa and Levodopa1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-458-01EA - Each59651-45865839bdd-b671-4bae-ac71-0e3a69d23f9912023-05-05
59651-458-05EA - Each59651-4581e284dc0-cde8-4cae-bdca-256471c35bac12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-458CARBIDOPA AND LEVODOPA TABLET [AUROBINDO PHARMA LIMITED]2Current NDC, Legacy NDC, 3 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
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSN57688b2c-7be0-4e73-9b4f-7ec3b5dc1c371
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSN998f805d-da97-484e-a931-e409e8b8c65a1
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCD57688b2c-7be0-4e73-9b4f-7ec3b5dc1c371
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCD998f805d-da97-484e-a931-e409e8b8c65a1
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSY57688b2c-7be0-4e73-9b4f-7ec3b5dc1c371
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSY998f805d-da97-484e-a931-e409e8b8c65a1
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSY57688b2c-7be0-4e73-9b4f-7ec3b5dc1c371
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSY998f805d-da97-484e-a931-e409e8b8c65a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-458-0159651045801100 TABLET in 1 BOTTLE (59651-458-01) 100 tablet2022-11-280000-00-00NoNoCurrent
59651-458-0559651045805500 TABLET in 1 BOTTLE (59651-458-05) 500 tablet2022-11-280000-00-00NoNoCurrent
59651-458-99596510458991000 TABLET in 1 BOTTLE (59651-458-99) 1000 tablet2022-11-280000-00-00NoNoCurrent