FDA.reportPublic FDA data

Carbidopa and Levodopa

Product NDC
63629-4134
11-digit product format
636294134
Labeler code
63629
Product ID
63629-4134_ff612022-6924-42dc-b4cb-bb0d16c209f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA216537
Marketing category
ANDA
Marketing start
2022-11-28
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
UniiMNX7R8C5VO, 46627O600J
Rxcui197445

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
63629-4134-1Carbidopa and Levodopa30 in 1 BOTTLETABLET301
63629-4134-2Carbidopa and Levodopa270 in 1 BOTTLETABLET2701
63629-4134-3Carbidopa and Levodopa60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4134CARBIDOPA AND LEVODOPA TABLET [BRYANT RANCH PREPACK]1Current NDC, 3 package rows20250410_998f805d-da97-484e-a931-e409e8b8c65a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSN998f805d-da97-484e-a931-e409e8b8c65a1
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCD998f805d-da97-484e-a931-e409e8b8c65a1
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSY998f805d-da97-484e-a931-e409e8b8c65a1
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSY998f805d-da97-484e-a931-e409e8b8c65a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-4134-16362941340130 TABLET in 1 BOTTLE (63629-4134-1) 30 tablet2025-04-07NoNoHistorical
63629-4134-263629413402270 TABLET in 1 BOTTLE (63629-4134-2) 270 tablet2025-04-07NoNoHistorical
63629-4134-36362941340360 TABLET in 1 BOTTLE (63629-4134-3) 60 tablet2025-04-07NoNoHistorical