Home NDC 43353-996 Entacapone
Product NDC 43353-996
11-digit product format 433530996
Labeler code 43353
Product ID 43353-996_7c029405-5ed3-4194-9dc9-a295dc779170
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Entacapone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application NDA020796
Marketing category NDA
Marketing start 2012-09-30
Marketing end 0000-00-00
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 2020-12-31
Current FDA listing Historical FDA.report record 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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43353-996-83 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43353-996-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43353-996-83 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43353-996-05 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 43353-996-83 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 43353-996-05 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 43353-996-83 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 43353-996-05 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 43353-996-83 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 43353-996-05 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 43353-996-83 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 43353-996-05 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 43353-996-83 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 43353-996-05 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 43353-996-83 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 43353-996-05 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 43353-996-83 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 43353-996-05 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 43353-996-83 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 43353-996-05 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 43353-996-83 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 43353-996-05 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 43353-996-83 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 43353-996-05 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 43353-996-83 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 43353-996-05 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 43353-996-83 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 43353-996-05 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 43353-996-83 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 43353-996-05 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product E Excluded after deficient or non-compliant submission was not corrected fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 43353-996-05 E Excluded after deficient or non-compliant submission was not corrected fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 43353-996-83 E Excluded after deficient or non-compliant submission was not corrected fb8cb913e6d1…eb8c232b6be0…
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 N020796-001 COMTAN ENTACAPONE 200MG TABLET / ORAL AB RLD, RS 1999-10-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020796-001 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 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020796-001 COMTAN 200MG TABLET / ORAL AB RLD, RS 1999-10-19 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43353-996-05 Entacapone 4200 in 1 BOTTLE TABLET, FILM COATED 4200 3 43353-996-83 Entacapone 3600 in 1 BOTTLE TABLET, FILM COATED 3600 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-996 ENTACAPONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 Legacy NDC, 2 package rows 20191231_78278e3a-cc95-49ac-89ea-b49f0d63fc46.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 43353-996-05 43353099605 4200 TABLET, FILM COATED in 1 BOTTLE (43353-996-05) 2015-02-14 0000-00-00 No No Current 43353-996-83 43353099683 3600 TABLET, FILM COATED in 1 BOTTLE (43353-996-83) 2017-09-08 0000-00-00 No No Current