FDA.reportPublic FDA data

Carbidopa and Levodopa

Product NDC
0615-8460
11-digit product format
006158460
Labeler code
0615
Product ID
0615-8460_bd08f206-2051-4ac7-b4ac-b0b83a79029d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA214091
Marketing category
ANDA
Marketing start
2021-10-05
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
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
LEVODOPA100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii46627O600J, MNX7R8C5VO
Rxcui308988, 308989

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
0615-8460-39Carbidopa and Levodopa30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8460CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]2Current NDC, 1 package rows20240915_ef0be743-e6f3-4662-8b0c-53f1eda4638a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletPSNef0be743-e6f3-4662-8b0c-53f1eda4638a2
308989carbidopa 50 MG / levodopa 200 MG Extended Release Oral TabletPSNef0be743-e6f3-4662-8b0c-53f1eda4638a2
308988carbidopa 25 MG / levodopa 100 MG Extended Release Oral TabletSCDef0be743-e6f3-4662-8b0c-53f1eda4638a2
308989carbidopa 50 MG / levodopa 200 MG Extended Release Oral TabletSCDef0be743-e6f3-4662-8b0c-53f1eda4638a2
308988carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Extended Release Oral TabletSYef0be743-e6f3-4662-8b0c-53f1eda4638a2
308989carbidopa (as carbidopa monohydrate) 50 MG / levodopa 200 MG Extended Release Oral TabletSYef0be743-e6f3-4662-8b0c-53f1eda4638a2
308988Carbidopa 25 MG / L-DOPA 100 MG Extended Release Oral TabletSYef0be743-e6f3-4662-8b0c-53f1eda4638a2
308989Carbidopa 50 MG / L-DOPA 200 MG Extended Release Oral TabletSYef0be743-e6f3-4662-8b0c-53f1eda4638a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0615-8460-390061584603930 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8460-39) 2023-03-28NoNoCurrent