FDA.reportPublic FDA data

carbidopa, levodopa and entacapone

Product NDC
46708-797
11-digit product format
467080797
Labeler code
46708
Product ID
46708-797_9ff83838-b7d0-4eec-98f2-fcc85789a189
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbidopa, levodopa and entacapone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA218535
Marketing category
ANDA
Marketing start
2026-02-12
Substance
CARBIDOPA; ENTACAPONE; LEVODOPA
Active strength
25; 200; 100 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
CARBIDOPA25 mg/1
ENTACAPONE200 mg/1
LEVODOPA100 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
46708-797-31carbidopa, levodopa and entacapone100 in 1 BOTTLETABLET, FILM COATED1001
46708-797-91carbidopa, levodopa and entacapone1000 in 1 BOTTLETABLET, FILM COATED10001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403850carbidopa 12.5 MG / levodopa 50 MG / entacapone 200 MG Oral TabletPSN9ff83838-b7d0-4eec-98f2-fcc85789a1891
810090carbidopa 18.75 MG / levodopa 75 MG / entacapone 200 MG Oral TabletPSN9ff83838-b7d0-4eec-98f2-fcc85789a1891
403851carbidopa 25 MG / levodopa 100 MG / entacapone 200 MG Oral TabletPSN9ff83838-b7d0-4eec-98f2-fcc85789a1891
810083carbidopa 31.25 MG / levodopa 125 MG / entacapone 200 MG Oral TabletPSN9ff83838-b7d0-4eec-98f2-fcc85789a1891
403852carbidopa 37.5 MG / levodopa 150 MG / entacapone 200 MG Oral TabletPSN9ff83838-b7d0-4eec-98f2-fcc85789a1891
730988carbidopa 50 MG / levodopa 200 MG / entacapone 200 MG Oral TabletPSN9ff83838-b7d0-4eec-98f2-fcc85789a1891
403850carbidopa 12.5 MG / entacapone 200 MG / levodopa 50 MG Oral TabletSCD9ff83838-b7d0-4eec-98f2-fcc85789a1891
810090carbidopa 18.75 MG / entacapone 200 MG / levodopa 75 MG Oral TabletSCD9ff83838-b7d0-4eec-98f2-fcc85789a1891
403851carbidopa 25 MG / entacapone 200 MG / levodopa 100 MG Oral TabletSCD9ff83838-b7d0-4eec-98f2-fcc85789a1891
810083carbidopa 31.25 MG / entacapone 200 MG / levodopa 125 MG Oral TabletSCD9ff83838-b7d0-4eec-98f2-fcc85789a1891
403852carbidopa 37.5 MG / entacapone 200 MG / levodopa 150 MG Oral TabletSCD9ff83838-b7d0-4eec-98f2-fcc85789a1891
730988carbidopa 50 MG / entacapone 200 MG / levodopa 200 MG Oral TabletSCD9ff83838-b7d0-4eec-98f2-fcc85789a1891
403850Carbidopa 12.5 MG / entacapone 200 MG / L-DOPA 50 MG Oral TabletSY9ff83838-b7d0-4eec-98f2-fcc85789a1891
810090Carbidopa 18.75 MG / entacapone 200 MG / L-DOPA 75 MG Oral TabletSY9ff83838-b7d0-4eec-98f2-fcc85789a1891
403851Carbidopa 25 MG / entacapone 200 MG / L-DOPA 100 MG Oral TabletSY9ff83838-b7d0-4eec-98f2-fcc85789a1891
810083Carbidopa 31.25 MG / entacapone 200 MG / L-DOPA 125 MG Oral TabletSY9ff83838-b7d0-4eec-98f2-fcc85789a1891
403852Carbidopa 37.5 MG / entacapone 200 MG / L-DOPA 150 MG Oral TabletSY9ff83838-b7d0-4eec-98f2-fcc85789a1891
730988Carbidopa 50 MG / entacapone 200 MG / L-DOPA 200 MG Oral TabletSY9ff83838-b7d0-4eec-98f2-fcc85789a1891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
46708-797-3146708079731100 TABLET, FILM COATED in 1 BOTTLE (46708-797-31) 2026-02-12NoNoCurrent
46708-797-91467080797911000 TABLET, FILM COATED in 1 BOTTLE (46708-797-91) 2026-02-12NoNoCurrent