FDA.reportPublic FDA data

Carbidopa, Levodopa and Entacapone

Product NDC
33342-491
11-digit product format
333420491
Labeler code
33342
Product ID
33342-491_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
2024-04-15
Substance
CARBIDOPA; ENTACAPONE; LEVODOPA
Active strength
12.5; 200; 50 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214495-001CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPA12.5MG;200MG;50MGTABLET / ORALAB2025-04-15
A214495-002CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPA18.75MG;200MG;75MGTABLET / ORALAB2025-04-15
A214495-003CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPA25MG;200MG;100MGTABLET / ORALAB2025-04-15
A214495-004CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPA31.25MG;200MG;125MGTABLET / ORALAB2025-04-15
A214495-005CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPA37.5MG;200MG;150MGTABLET / ORALAB2025-04-15
A214495-006CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPA50MG;200MG;200MGTABLET / ORALAB2025-04-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A214495-001AB
A214495-002AB
A214495-003AB
A214495-004AB
A214495-005AB
A214495-006AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214495-001CARBIDOPA, LEVODOPA AND ENTACAPONE12.5MG;200MG;50MGTABLET / ORALAB2025-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214495-002CARBIDOPA, LEVODOPA AND ENTACAPONE18.75MG;200MG;75MGTABLET / ORALAB2025-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214495-003CARBIDOPA, LEVODOPA AND ENTACAPONE25MG;200MG;100MGTABLET / ORALAB2025-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214495-004CARBIDOPA, LEVODOPA AND ENTACAPONE31.25MG;200MG;125MGTABLET / ORALAB2025-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214495-005CARBIDOPA, LEVODOPA AND ENTACAPONE37.5MG;200MG;150MGTABLET / ORALAB2025-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214495-006CARBIDOPA, LEVODOPA AND ENTACAPONE50MG;200MG;200MGTABLET / ORALAB2025-04-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214495-001CARBIDOPA, LEVODOPA AND ENTACAPONE12.5MG;200MG;50MGTABLET / ORALAB2025-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214495-002CARBIDOPA, LEVODOPA AND ENTACAPONE18.75MG;200MG;75MGTABLET / ORALAB2025-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214495-003CARBIDOPA, LEVODOPA AND ENTACAPONE25MG;200MG;100MGTABLET / ORALAB2025-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214495-004CARBIDOPA, LEVODOPA AND ENTACAPONE31.25MG;200MG;125MGTABLET / ORALAB2025-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214495-005CARBIDOPA, LEVODOPA AND ENTACAPONE37.5MG;200MG;150MGTABLET / ORALAB2025-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214495-006CARBIDOPA, LEVODOPA AND ENTACAPONE50MG;200MG;200MGTABLET / ORALAB2025-04-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A214495-001CARBIDOPA, LEVODOPA AND ENTACAPONE12.5MG;200MG;50MGTABLET / ORALAB2025-04-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214495-002CARBIDOPA, LEVODOPA AND ENTACAPONE18.75MG;200MG;75MGTABLET / ORALAB2025-04-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214495-003CARBIDOPA, LEVODOPA AND ENTACAPONE25MG;200MG;100MGTABLET / ORALAB2025-04-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214495-004CARBIDOPA, LEVODOPA AND ENTACAPONE31.25MG;200MG;125MGTABLET / ORALAB2025-04-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214495-005CARBIDOPA, LEVODOPA AND ENTACAPONE37.5MG;200MG;150MGTABLET / ORALAB2025-04-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214495-006CARBIDOPA, LEVODOPA AND ENTACAPONE50MG;200MG;200MGTABLET / ORALAB2025-04-156a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214495-001CARBIDOPA, LEVODOPA AND ENTACAPONE12.5MG;200MG;50MGTABLET / ORALAB2025-04-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214495-002CARBIDOPA, LEVODOPA AND ENTACAPONE18.75MG;200MG;75MGTABLET / ORALAB2025-04-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214495-003CARBIDOPA, LEVODOPA AND ENTACAPONE25MG;200MG;100MGTABLET / ORALAB2025-04-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214495-004CARBIDOPA, LEVODOPA AND ENTACAPONE31.25MG;200MG;125MGTABLET / ORALAB2025-04-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214495-005CARBIDOPA, LEVODOPA AND ENTACAPONE37.5MG;200MG;150MGTABLET / ORALAB2025-04-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214495-006CARBIDOPA, LEVODOPA AND ENTACAPONE50MG;200MG;200MGTABLET / ORALAB2025-04-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214495-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214495-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214495-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214495-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214495-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214495-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214495-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214495-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214495-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214495-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214495-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214495-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214495-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214495-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214495-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214495-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214495-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214495-006AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214495-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214495-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214495-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214495-004AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214495-005AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214495-006AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Carbidopa, Levodopa and Entacapone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBIDOPA12.5 mg/1
LEVODOPA200 mg/1
ENTACAPONE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4975G9NM6TInternal UNII lookup
MNX7R8C5VOInternal UNII lookup
46627O600JInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
403850Internal RxNorm lookup
403851Internal RxNorm lookup
403852Internal RxNorm lookup
730988Internal RxNorm lookup
810083Internal RxNorm lookup
810090Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f0d9d7a8-1d06-4119-b2bc-42b3ec08d45bAvailable on FDA.report

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
33342-491-11Carbidopa, Levodopa and Entacapone100 in 1 BOTTLETABLET, FILM COATED1002
33342-491-12Carbidopa, Levodopa and Entacapone10 in 1 BLISTER PACKTABLET, FILM COATED102
33342-491-12Carbidopa, Levodopa and Entacapone10 in 1 CARTONTABLET, FILM COATED102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-491CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, 3 package rows20250504_f0d9d7a8-1d06-4119-b2bc-42b3ec08d45b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carbidopa, Levodopa and EntacaponeCARBIDOPA, LEVODOPA AND ENTACAPONEMacleods Pharmaceuticals Limitedf0d9d7a8-1d06-4119-b2bc-42b3ec08d45b2026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214495
application number: ANDA214495
ndc (product): 33342-491

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
33342-491-1133342049111100 TABLET, FILM COATED in 1 BOTTLE (33342-491-11) 2025-04-15NoNoCurrent
33342-491-123334204911210 BLISTER PACK in 1 CARTON (33342-491-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2025-04-15NoNoCurrent