FDA.reportPublic FDA data

Carbidopa and Levodopa

Product NDC
50090-7498
11-digit product format
500907498
Labeler code
50090
Product ID
50090-7498_8d6d26e6-0897-4247-a532-13c02ecc5f2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA216537
Marketing category
ANDA
Marketing start
2022-11-28
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
UniiMNX7R8C5VO, 46627O600J
Rxcui197444

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
50090-7498-1Carbidopa and Levodopa90 in 1 BOTTLETABLET901
50090-7498-2Carbidopa and Levodopa270 in 1 BOTTLETABLET2701
50090-7498-3Carbidopa and Levodopa360 in 1 BOTTLETABLET3601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7498-1EA - Each50090-7498f9c3a1b5-369f-408a-b9de-366bdd21968912025-02-10
50090-7498-2EA - Each50090-7498f6264aaf-37ad-42f4-ab28-0dc1734a3e1312025-02-10
50090-7498-3EA - Each50090-74982ec9102e-848d-4d81-ac95-e3001031818f12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7498CARBIDOPA AND LEVODOPA TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20250124_ea1dd532-9fb3-47c2-863c-b288ca7bb24e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSNea1dd532-9fb3-47c2-863c-b288ca7bb24e1
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCDea1dd532-9fb3-47c2-863c-b288ca7bb24e1
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSYea1dd532-9fb3-47c2-863c-b288ca7bb24e1
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSYea1dd532-9fb3-47c2-863c-b288ca7bb24e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7498-15009074980190 TABLET in 1 BOTTLE (50090-7498-1) 90 tablet2025-01-21NoNoHistorical
50090-7498-250090749802270 TABLET in 1 BOTTLE (50090-7498-2) 270 tablet2025-01-21NoNoHistorical
50090-7498-350090749803360 TABLET in 1 BOTTLE (50090-7498-3) 360 tablet2025-01-21NoNoHistorical