Home NDC 50268-295 Entacapone
Product NDC 50268-295
11-digit product format 502680295
Labeler code 50268
Product ID 50268-295_47e3561c-c311-d3fd-e063-6394a90ae2cc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Entacapone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AvPAK
Application ANDA203437
Marketing category ANDA
Marketing start 2016-12-05
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 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 A203437-001 ENTACAPONE ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203437-001 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 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 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 50268-295-11 Entacapone 1 in 1 BLISTER PACK TABLET, FILM COATED 1 7 50268-295-15 Entacapone 50 in 1 BOX, UNIT-DOSE TABLET, FILM COATED 50 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-295 ENTACAPONE TABLET, FILM COATED [AVPAK] 6 Current NDC, Legacy NDC, 2 package rows 20220517_1fab63f2-9257-6998-5658-7e98db51b184.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 · 4 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 50268-295-11 50268029511 1 in 1 BLISTER PACK Historical 50268-295-15 50268029515 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-295-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-295-11) 50 blister pack 2016-12-05 0000-00-00 No No Current