FDA.reportPublic FDA data

Carbidopa and levodopa

Product NDC
42291-488
11-digit product format
422910488
Labeler code
42291
Product ID
42291-488_485f790b-2d36-cffd-e063-6294a90a1cb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and levodopa
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA074260
Marketing category
ANDA
Marketing start
2024-02-21
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
Rxcui197445

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
42291-488-01Carbidopa and levodopa100 in 1 BOTTLETABLET1002
42291-488-10Carbidopa and levodopa1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-488-01EA - Each42291-488cf8ce329-5159-41fb-9c81-f170cf86bc6d12024-03-12
42291-488-10EA - Each42291-488eeea970f-e08a-4bd2-ab9a-3ad65f20590b12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-488CARBIDOPA AND LEVODOPA TABLET [AVKARE]1Current NDC, 2 package rows20240223_11e706c4-433c-1ea6-e063-6294a90ad360.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSN11e706c4-433c-1ea6-e063-6294a90ad3602
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCD11e706c4-433c-1ea6-e063-6294a90ad3602
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSY11e706c4-433c-1ea6-e063-6294a90ad3602
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSY11e706c4-433c-1ea6-e063-6294a90ad3602

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42291-488-0142291048801100 TABLET in 1 BOTTLE (42291-488-01) 100 tablet2024-02-21NoNoHistorical
42291-488-10422910488101000 TABLET in 1 BOTTLE (42291-488-10) 1000 tablet2024-02-21NoNoHistorical