Home NDC 64679-781 Entacapone
Product NDC 64679-781
11-digit product format 646790781
Labeler code 64679
Product ID 64679-781_b6bfa61c-117f-497c-acc4-98b926fbdac1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Entacapone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Wockhardt USA 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 2021-12-31
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 · 33 matching rows.
View current auxiliary records. · View the auxiliary file history.
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# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ENTACAPONE ACTIVE INGREDIENT 4975G9NM6T ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 2 ENTACAPONE ACTIVE MOIETY 4975G9NM6T ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 2 HYDROGENATED COTTONSEED OIL INACTIVE INGREDIENT Z82Y2C65EA ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 2 MANNITOL INACTIVE INGREDIENT 3OWL53L36A ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ENTACAPONE TABLET, FILM COATED [WOCKHARDT USA LLC.] 2
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 Units Marketing start Marketing end Sample Exclude flag Status 64679-781-02 64679078102 1 BOTTLE in 1 CARTON (64679-781-02) > 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2012-10-01 0000-00-00 No No Current 64679-781-03 64679078103 500 TABLET, FILM COATED in 1 BOTTLE (64679-781-03) 2012-10-01 0000-00-00 No No Current