Home NDC 33342-260 Entacapone
Product NDC 33342-260
11-digit product format 333420260
Labeler code 33342
Product ID 33342-260_000701ed-32a2-4b57-acb3-41c3b5ad869e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Entacapone
Dosage form TABLET
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA207210
Marketing category ANDA
Marketing start 2017-06-06
Substance ENTACAPONE
Active strength 200 mg/1
Pharmacologic classes Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 33342-260-11 ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 33342-260-15 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 33342-260-11 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 33342-260-15 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207210-001 ENTACAPONE ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207210-001 AB
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.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207210-001 ENTACAPONE 200MG TABLET / ORAL AB 2017-06-05 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Entacapone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENTACAPONE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4975G9NM6T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 317094 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 33342-260-11 Entacapone 100 in 1 BOTTLE TABLET 100 7 33342-260-15 Entacapone 500 in 1 BOTTLE TABLET 500 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-260 ENTACAPONE TABLET [MACLEODS PHARMACEUTICALS LIMITED] 6 Current NDC, Legacy NDC, 2 package rows 20250121_56327e32-3b06-4144-91a0-bb1908842e33.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 33342-260-11 33342026011 100 TABLET in 1 BOTTLE (33342-260-11) 100 tablet 2017-06-06 0000-00-00 No No Current 33342-260-15 33342026015 500 TABLET in 1 BOTTLE (33342-260-15) 500 tablet 2017-06-06 0000-00-00 No No Current