FDA.reportPublic FDA data

CARBIDOPA AND LEVODOPA

Product NDC
72865-362
11-digit product format
728650362
Labeler code
72865
Product ID
72865-362_28322507-e9f9-4b18-9f4b-ed28bb0a83bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET
Route
ORAL
Labeler
XLCare Pharmaceuticals, Inc.
Application
ANDA218939
Marketing category
ANDA
Marketing start
2026-01-19
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
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
LEVODOPA100 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
72865-362-01CARBIDOPA AND LEVODOPA100 in 1 BOTTLETABLET1002
72865-362-10CARBIDOPA AND LEVODOPA1000 in 1 BOTTLETABLET10002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197443carbidopa 10 MG / levodopa 100 MG Oral TabletPSN0c630a24-dc51-4601-a5d6-2f9e397a04492
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN0c630a24-dc51-4601-a5d6-2f9e397a04492
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSN0c630a24-dc51-4601-a5d6-2f9e397a04492
197443carbidopa 10 MG / levodopa 100 MG Oral TabletSCD0c630a24-dc51-4601-a5d6-2f9e397a04492
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD0c630a24-dc51-4601-a5d6-2f9e397a04492
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCD0c630a24-dc51-4601-a5d6-2f9e397a04492
197443carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral TabletSY0c630a24-dc51-4601-a5d6-2f9e397a04492
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY0c630a24-dc51-4601-a5d6-2f9e397a04492
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSY0c630a24-dc51-4601-a5d6-2f9e397a04492
197443Carbidopa 10 MG / L-DOPA 100 MG Oral TabletSY0c630a24-dc51-4601-a5d6-2f9e397a04492
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY0c630a24-dc51-4601-a5d6-2f9e397a04492
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSY0c630a24-dc51-4601-a5d6-2f9e397a04492

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72865-362-0172865036201100 TABLET in 1 BOTTLE (72865-362-01) 100 tablet2026-01-19NoNoCurrent
72865-362-10728650362101000 TABLET in 1 BOTTLE (72865-362-10) 1000 tablet2026-01-19NoNoCurrent