FDA.reportPublic FDA data

Carbidopa and levodopa

Product NDC
0228-2539
11-digit product format
002282539
Labeler code
0228
Product ID
0228-2539_05c2553d-9cc1-42e9-9cc7-30cdde68a6e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA074260
Marketing category
ANDA
Marketing start
1993-09-01
Marketing end
2024-11-30
Substance
CARBIDOPA; LEVODOPA
Active strength
25 mg/1; mg/1
Pharmacologic classes
Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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
0228-2539-10Carbidopa and levodopa100 in 1 BOTTLETABLET10021
0228-2539-50Carbidopa and levodopa500 in 1 BOTTLETABLET50021
0228-2539-96Carbidopa and levodopa1000 in 1 BOTTLETABLET100021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-2539-10EA - Each0228-253913906b03-f91c-4b8b-92e8-205f0762984c12012-07-24
0228-2539-50EA - Each0228-2539a258a732-d480-4651-aadf-5eece592e5cb12012-07-24
0228-2539-96EA - Each0228-253956cb7555-b069-422a-bed3-62a24d33c1c412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBIDOPAACTIVE INGREDIENTMNX7R8C5VOCARBIDOPA AND LEVODOPA TABLET [ACTAVIS PHARMA, INC.]6
LEVODOPAACTIVE INGREDIENT46627O600JCARBIDOPA AND LEVODOPA TABLET [ACTAVIS PHARMA, INC.]6
CARBIDOPA ANHYDROUSACTIVE MOIETYKR87B45RGHCARBIDOPA AND LEVODOPA TABLET [ACTAVIS PHARMA, INC.]6
LEVODOPAACTIVE MOIETY46627O600JCARBIDOPA AND LEVODOPA TABLET [ACTAVIS PHARMA, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARBIDOPA AND LEVODOPA TABLET [ACTAVIS PHARMA, INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCARBIDOPA AND LEVODOPA TABLET [ACTAVIS PHARMA, INC.]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCARBIDOPA AND LEVODOPA TABLET [ACTAVIS PHARMA, INC.]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CARBIDOPA AND LEVODOPA TABLET [ACTAVIS PHARMA, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBIDOPA AND LEVODOPA TABLET [ACTAVIS PHARMA, INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARBIDOPA AND LEVODOPA TABLET [ACTAVIS PHARMA, INC.]6
CARBIDOPAACTIVE INGREDIENTMNX7R8C5VOCARBIDOPA AND LEVODOPA TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
LEVODOPAACTIVE INGREDIENT46627O600JCARBIDOPA AND LEVODOPA TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
CARBIDOPA ANHYDROUSACTIVE MOIETYKR87B45RGHCARBIDOPA AND LEVODOPA TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
LEVODOPAACTIVE MOIETY46627O600JCARBIDOPA AND LEVODOPA TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARBIDOPA AND LEVODOPA TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCARBIDOPA AND LEVODOPA TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CARBIDOPA AND LEVODOPA TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBIDOPA AND LEVODOPA TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARBIDOPA AND LEVODOPA TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-2539CARBIDOPA AND LEVODOPA TABLET [ACTAVIS PHARMA, INC.]21Legacy NDC, 3 package rows20240307_a355d5f2-407d-40fa-a374-b3632261ea4a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN8f03374a-70a1-45e8-83e7-ee0f3f0541a11
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD8f03374a-70a1-45e8-83e7-ee0f3f0541a11
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY8f03374a-70a1-45e8-83e7-ee0f3f0541a11
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY8f03374a-70a1-45e8-83e7-ee0f3f0541a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0228-2539-1000228253910100 TABLET in 1 BOTTLE (0228-2539-10) 100 tablet1993-09-012024-10-31NoNoCurrent
0228-2539-5000228253950500 TABLET in 1 BOTTLE (0228-2539-50) 500 tablet1993-09-012024-11-30NoNoCurrent
0228-2539-96002282539961000 TABLET in 1 BOTTLE (0228-2539-96) 1000 tablet1993-09-010000-00-00NoNoCurrent