Home NDC 71610-247 Entacapone
Product NDC 71610-247
11-digit product format 716100247
Labeler code 71610
Product ID 71610-247_a3c90a47-42cb-44b6-99e0-f027dc45ac2b
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 AUTHORIZED GENERIC
Marketing start 2014-06-04
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 2026-12-31
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 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.
Additional Listing Data#
Finished product Yes
Brand name base Entacapone
Listing expiration 2026-12-31 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 71610-247-83 Entacapone 3600 in 1 BOTTLE TABLET, FILM COATED 3600 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-247 ENTACAPONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Current NDC, Legacy NDC, 1 package rows 20190315_32d30f97-ae0f-4d02-bdd7-75e0783d66bc.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 71610-247-83 71610024783 3600 TABLET, FILM COATED in 1 BOTTLE (71610-247-83) 2019-03-07 0000-00-00 No No Current