FDA.reportPublic FDA data

Carbidopa and Levodopa

Product NDC
0615-8516
11-digit product format
006158516
Labeler code
0615
Product ID
0615-8516_4bccc4b9-7399-4dd4-9146-c5b2714f299f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA073607
Marketing category
ANDA
Marketing start
2024-05-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Carbidopa and Levodopa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBIDOPA25 mg/1
LEVODOPA250 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
0615-8516-39Carbidopa and Levodopa30 in 1 BLISTER PACKTABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8516CARBIDOPA AND LEVODOPA TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]5Current NDC, 1 package rows20241208_45909de3-0852-4e61-8a9e-23f8fcc2463a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197443carbidopa 10 MG / levodopa 100 MG Oral TabletPSN45909de3-0852-4e61-8a9e-23f8fcc2463a5
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN45909de3-0852-4e61-8a9e-23f8fcc2463a5
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSN45909de3-0852-4e61-8a9e-23f8fcc2463a5
197443carbidopa 10 MG / levodopa 100 MG Oral TabletSCD45909de3-0852-4e61-8a9e-23f8fcc2463a5
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD45909de3-0852-4e61-8a9e-23f8fcc2463a5
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCD45909de3-0852-4e61-8a9e-23f8fcc2463a5
197443carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral TabletSY45909de3-0852-4e61-8a9e-23f8fcc2463a5
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY45909de3-0852-4e61-8a9e-23f8fcc2463a5
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSY45909de3-0852-4e61-8a9e-23f8fcc2463a5
197443Carbidopa 10 MG / L-DOPA 100 MG Oral TabletSY45909de3-0852-4e61-8a9e-23f8fcc2463a5
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY45909de3-0852-4e61-8a9e-23f8fcc2463a5
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSY45909de3-0852-4e61-8a9e-23f8fcc2463a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0615-8516-390061585163930 TABLET in 1 BLISTER PACK (0615-8516-39) 30 tablet2024-11-27NoNoCurrent