FDA.reportPublic FDA data

Carbidopa and Levodopa

Product NDC
50228-458
11-digit product format
502280458
Labeler code
50228
Product ID
50228-458_3b66d16c-654c-4dcb-ad04-3503aa7f1ca5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET
Route
ORAL
Labeler
ScieGen Pharmaceuticals Inc
Application
ANDA214092
Marketing category
ANDA
Marketing start
2021-05-07
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
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
50228-458-01Carbidopa and Levodopa100 in 1 BOTTLETABLET1003
50228-458-05Carbidopa and Levodopa500 in 1 BOTTLETABLET5003
50228-458-10Carbidopa and Levodopa1000 in 1 BOTTLETABLET10003
50228-458-30Carbidopa and Levodopa30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-458CARBIDOPA AND LEVODOPA TABLET [SCIEGEN PHARMACEUTICALS INC]2Current NDC, Legacy NDC, 4 package rows20230108_a32afa84-7bc0-4bd3-bc50-55d738f3d7ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN7219022c-a56a-4501-9437-601f6cb34e6b5
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSNf207467e-ac62-446a-b42e-371efd0c7b2b5
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCDf207467e-ac62-446a-b42e-371efd0c7b2b5
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD7219022c-a56a-4501-9437-601f6cb34e6b5
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSYf207467e-ac62-446a-b42e-371efd0c7b2b5
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY7219022c-a56a-4501-9437-601f6cb34e6b5
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSYf207467e-ac62-446a-b42e-371efd0c7b2b5
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY7219022c-a56a-4501-9437-601f6cb34e6b5
197443carbidopa 10 MG / levodopa 100 MG Oral TabletPSNa32afa84-7bc0-4bd3-bc50-55d738f3d7ce3
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN289ca0b7-1b4f-4653-b329-066447d18c133
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSNa32afa84-7bc0-4bd3-bc50-55d738f3d7ce3
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSNa32afa84-7bc0-4bd3-bc50-55d738f3d7ce3
197443carbidopa 10 MG / levodopa 100 MG Oral TabletSCDa32afa84-7bc0-4bd3-bc50-55d738f3d7ce3
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCDa32afa84-7bc0-4bd3-bc50-55d738f3d7ce3
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD289ca0b7-1b4f-4653-b329-066447d18c133
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCDa32afa84-7bc0-4bd3-bc50-55d738f3d7ce3
197443carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral TabletSYa32afa84-7bc0-4bd3-bc50-55d738f3d7ce3
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSYa32afa84-7bc0-4bd3-bc50-55d738f3d7ce3
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY289ca0b7-1b4f-4653-b329-066447d18c133
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSYa32afa84-7bc0-4bd3-bc50-55d738f3d7ce3
197443Carbidopa 10 MG / L-DOPA 100 MG Oral TabletSYa32afa84-7bc0-4bd3-bc50-55d738f3d7ce3
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSYa32afa84-7bc0-4bd3-bc50-55d738f3d7ce3
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY289ca0b7-1b4f-4653-b329-066447d18c133
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSYa32afa84-7bc0-4bd3-bc50-55d738f3d7ce3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-458-0150228045801100 TABLET in 1 BOTTLE (50228-458-01) 100 tablet2021-05-070000-00-00NoNoCurrent
50228-458-0550228045805500 TABLET in 1 BOTTLE (50228-458-05) 500 tablet2021-05-070000-00-00NoNoCurrent
50228-458-10502280458101000 TABLET in 1 BOTTLE (50228-458-10) 1000 tablet2021-05-070000-00-00NoNoCurrent
50228-458-305022804583030 TABLET in 1 BOTTLE (50228-458-30) 30 tablet2021-05-070000-00-00NoNoCurrent