Dhivy

Product NDC
75854-701
11-digit product format
758540701
Labeler code
75854
Product ID
75854-701_229fe84b-2986-42f6-877c-17d9da08b12c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa Levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Avion Pharmaceuticals, LLC
Application
NDA214869
Marketing category
NDA
Marketing start
2022-07-13
Substance
CARBIDOPA HYDRATE; 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
Dhivy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBIDOPA HYDRATE25 mg/1
LEVODOPA100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMNX7R8C5VO, 46627O600J
Rxcui197444, 2586032

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
75854-701-01Dhivy100 in 1 BOTTLETABLET10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75854-701-01EA - Each75854-701a04e2fbf-7a05-4235-80e2-c2a60c5df45312021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75854-701DHIVY (CARBIDOPA LEVODOPA) TABLET [AVION PHARMACEUTICALS, LLC]11Current NDC, Legacy NDC, 1 package rows20240202_39d79ade-8ee0-40ba-9fdd-13045b8ddbdf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN39d79ade-8ee0-40ba-9fdd-13045b8ddbdf13
2586032Dhivy 25 MG / 100 MG Oral TabletPSN39d79ade-8ee0-40ba-9fdd-13045b8ddbdf13
2586032carbidopa 25 MG / levodopa 100 MG Oral Tablet [Dhivy]SBD39d79ade-8ee0-40ba-9fdd-13045b8ddbdf13
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD39d79ade-8ee0-40ba-9fdd-13045b8ddbdf13
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY39d79ade-8ee0-40ba-9fdd-13045b8ddbdf13
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY39d79ade-8ee0-40ba-9fdd-13045b8ddbdf13
2586032carbidopa 25 MG / L-DOPA 100 MG Oral Tablet [Dhivy]SY39d79ade-8ee0-40ba-9fdd-13045b8ddbdf13
2586032Dhivy (carbidopa 25 MG / levodopa 100 MG) Oral TabletSY39d79ade-8ee0-40ba-9fdd-13045b8ddbdf13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75854-701-0175854070101100 TABLET in 1 BOTTLE (75854-701-01) 100 tablet2022-07-130000-00-00NoNoCurrent