FDA.reportPublic FDA data

Carbidopa, Levodopa and Entacapone

Product NDC
33342-495
11-digit product format
333420495
Labeler code
33342
Product ID
33342-495_ab41796a-b051-41fa-b8ee-e88b9236931a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa, Levodopa and Entacapone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA214495
Marketing category
ANDA
Marketing start
2025-04-15
Substance
CARBIDOPA; ENTACAPONE; LEVODOPA
Active strength
37.5; 200; 150 mg/1; mg/1; mg/1
Pharmacologic classes
Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [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, Levodopa and Entacapone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBIDOPA37.5 mg/1
ENTACAPONE200 mg/1
LEVODOPA150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMNX7R8C5VO, 46627O600J, 4975G9NM6T
Rxcui403850, 403851, 403852, 730988, 810083, 810090

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
6a098371-84f5-7ced-0ac5-ed90d535b476Product name620220927
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
33342-495-11Carbidopa, Levodopa and Entacapone100 in 1 BOTTLETABLET, FILM COATED1002
33342-495-12Carbidopa, Levodopa and Entacapone10 in 1 CARTONTABLET, FILM COATED102
33342-495-12Carbidopa, Levodopa and Entacapone10 in 1 BLISTER PACKTABLET, FILM COATED102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-495CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, 3 package rows20250504_f0d9d7a8-1d06-4119-b2bc-42b3ec08d45b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403850carbidopa 12.5 MG / levodopa 50 MG / entacapone 200 MG Oral TabletPSNf0d9d7a8-1d06-4119-b2bc-42b3ec08d45b2
810090carbidopa 18.75 MG / levodopa 75 MG / entacapone 200 MG Oral TabletPSNf0d9d7a8-1d06-4119-b2bc-42b3ec08d45b2
403851carbidopa 25 MG / levodopa 100 MG / entacapone 200 MG Oral TabletPSNf0d9d7a8-1d06-4119-b2bc-42b3ec08d45b2
810083carbidopa 31.25 MG / levodopa 125 MG / entacapone 200 MG Oral TabletPSNf0d9d7a8-1d06-4119-b2bc-42b3ec08d45b2
403852carbidopa 37.5 MG / levodopa 150 MG / entacapone 200 MG Oral TabletPSNf0d9d7a8-1d06-4119-b2bc-42b3ec08d45b2
730988carbidopa 50 MG / levodopa 200 MG / entacapone 200 MG Oral TabletPSNf0d9d7a8-1d06-4119-b2bc-42b3ec08d45b2
403850carbidopa 12.5 MG / entacapone 200 MG / levodopa 50 MG Oral TabletSCDf0d9d7a8-1d06-4119-b2bc-42b3ec08d45b2
810090carbidopa 18.75 MG / entacapone 200 MG / levodopa 75 MG Oral TabletSCDf0d9d7a8-1d06-4119-b2bc-42b3ec08d45b2
403851carbidopa 25 MG / entacapone 200 MG / levodopa 100 MG Oral TabletSCDf0d9d7a8-1d06-4119-b2bc-42b3ec08d45b2
810083carbidopa 31.25 MG / entacapone 200 MG / levodopa 125 MG Oral TabletSCDf0d9d7a8-1d06-4119-b2bc-42b3ec08d45b2
403852carbidopa 37.5 MG / entacapone 200 MG / levodopa 150 MG Oral TabletSCDf0d9d7a8-1d06-4119-b2bc-42b3ec08d45b2
730988carbidopa 50 MG / entacapone 200 MG / levodopa 200 MG Oral TabletSCDf0d9d7a8-1d06-4119-b2bc-42b3ec08d45b2
403850Carbidopa 12.5 MG / entacapone 200 MG / L-DOPA 50 MG Oral TabletSYf0d9d7a8-1d06-4119-b2bc-42b3ec08d45b2
810090Carbidopa 18.75 MG / entacapone 200 MG / L-DOPA 75 MG Oral TabletSYf0d9d7a8-1d06-4119-b2bc-42b3ec08d45b2
403851Carbidopa 25 MG / entacapone 200 MG / L-DOPA 100 MG Oral TabletSYf0d9d7a8-1d06-4119-b2bc-42b3ec08d45b2
810083Carbidopa 31.25 MG / entacapone 200 MG / L-DOPA 125 MG Oral TabletSYf0d9d7a8-1d06-4119-b2bc-42b3ec08d45b2
403852Carbidopa 37.5 MG / entacapone 200 MG / L-DOPA 150 MG Oral TabletSYf0d9d7a8-1d06-4119-b2bc-42b3ec08d45b2
730988Carbidopa 50 MG / entacapone 200 MG / L-DOPA 200 MG Oral TabletSYf0d9d7a8-1d06-4119-b2bc-42b3ec08d45b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-495-1133342049511100 TABLET, FILM COATED in 1 BOTTLE (33342-495-11) 2025-04-15NoNoCurrent
33342-495-123334204951210 BLISTER PACK in 1 CARTON (33342-495-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2025-04-15NoNoCurrent