FDA.reportPublic FDA data

Carbidopa-levodopa

Product NDC
52817-390
11-digit product format
528170390
Labeler code
52817
Product ID
52817-390_f8d2095e-d709-7b97-e053-6294a90af7d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbidopa and levodopa
Dosage form
TABLET
Route
ORAL
Labeler
TruPharma, LLC
Application
ANDA216505
Marketing category
ANDA
Marketing start
2022-09-21
Substance
CARBIDOPA; LEVODOPA
Active strength
10; 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-levodopa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBIDOPA10 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
52817-390-10Carbidopa-levodopa100 in 1 BOTTLETABLET1001
52817-390-50Carbidopa-levodopa500 in 1 BOTTLETABLET5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-390-10EA - Each52817-390fda26c18-da2e-404b-967e-5d17753c944a12023-05-05
52817-390-50EA - Each52817-390cfb27a42-2111-4d08-aff4-aa9c244d7dc512023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-390CARBIDOPA-LEVODOPA (CARBIDOPA AND LEVODOPA) TABLET [TRUPHARMA, LLC]1Current NDC, 2 package rows20230409_d1bb319b-82a3-4b66-9cdc-f77fdb8383ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197443carbidopa 10 MG / levodopa 100 MG Oral TabletPSNd1bb319b-82a3-4b66-9cdc-f77fdb8383ce1
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSNd1bb319b-82a3-4b66-9cdc-f77fdb8383ce1
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSNd1bb319b-82a3-4b66-9cdc-f77fdb8383ce1
197443carbidopa 10 MG / levodopa 100 MG Oral TabletSCDd1bb319b-82a3-4b66-9cdc-f77fdb8383ce1
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCDd1bb319b-82a3-4b66-9cdc-f77fdb8383ce1
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCDd1bb319b-82a3-4b66-9cdc-f77fdb8383ce1
197443carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral TabletSYd1bb319b-82a3-4b66-9cdc-f77fdb8383ce1
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSYd1bb319b-82a3-4b66-9cdc-f77fdb8383ce1
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSYd1bb319b-82a3-4b66-9cdc-f77fdb8383ce1
197443Carbidopa 10 MG / L-DOPA 100 MG Oral TabletSYd1bb319b-82a3-4b66-9cdc-f77fdb8383ce1
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSYd1bb319b-82a3-4b66-9cdc-f77fdb8383ce1
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSYd1bb319b-82a3-4b66-9cdc-f77fdb8383ce1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52817-390-1052817039010100 TABLET in 1 BOTTLE (52817-390-10) 100 tablet2023-04-04NoNoCurrent
52817-390-5052817039050500 TABLET in 1 BOTTLE (52817-390-50) 500 tablet2023-04-04NoNoCurrent