Home NDC 52483-0014 52483-0014
Product NDC 52483-0014
11-digit product format 524830014
Labeler code 52483
Product ID 52483-0014_4b3d81c5-dc8f-4b28-8a6e-8596dad3e759
Type DRUG FOR FURTHER PROCESSING
Nonproprietary name entacapone
Dosage form TABLET, FILM COATED
Marketing category DRUG FOR FURTHER PROCESSING
Marketing start 2014-03-24
Substance ENTACAPONE
Active strength 200 mg/1
Listing certified through 2026-12-31
Current FDA listing Yes NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 52483-0014 UNFINISHED Active or certified unfinished drug listing 2026-10-15 unfinished package package 52483-0014 52483-0014-0 UNFINISHED Active or certified unfinished drug listing 2026-10-15
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 · 42 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 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 52483-0014-0 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 52483-0014-0 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 52483-0014-0 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 52483-0014-0 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 52483-0014-0 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 52483-0014-0 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 52483-0014-0 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 52483-0014-0 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 52483-0014-0 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 52483-0014-0 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 52483-0014-0 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 52483-0014-0 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 52483-0014-0 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 52483-0014-0 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 unfinished product product 906f6e251498…bf70b80e44f0…2022-04-09 23:13 UTC · source 2022-04-08 unfinished package package 52483-0014-0 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 unfinished product product 6db9cb8d1e19…3449e1ec5b70…2021-12-27 23:28 UTC · source 2021-12-27 unfinished package package 52483-0014-0 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 unfinished product product 8fc7167e32ce…e96bbc724034…2021-02-18 23:40 UTC · source 2021-02-18 unfinished package package 52483-0014-0 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 unfinished product product 4184dd79f89f…545327b3e20f…2020-12-18 03:04 UTC · source 2020-12-17 unfinished package package 52483-0014-0 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished product product 4bd3596a7b87…5c64c6f6865f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished package package 52483-0014-0 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 unfinished product product 263afe128892…91768de4ddbe…2019-12-08 06:16 UTC · source 2019-12-05 unfinished package package 52483-0014-0 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 unfinished product product 5b2001dcd8f5…54b53d4dc9e4…2019-06-01 22:24 UTC · source 2019-05-30 unfinished package package 52483-0014-0 5b2001dcd8f5…54b53d4dc9e4…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product No
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENTACAPONE 200 mg/1
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 [SANDOZ INC] 10 ENTACAPONE ACTIVE MOIETY 4975G9NM6T ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 HYDROGENATED COTTONSEED OIL INACTIVE INGREDIENT Z82Y2C65EA ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 MANNITOL INACTIVE INGREDIENT 3OWL53L36A ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 SUCROSE INACTIVE INGREDIENT C151H8M554 ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ENTACAPONE TABLET, FILM COATED [SANDOZ INC] 10
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Status 52483-0014-0 52483001400 1 BAG in 1 DRUM (52483-0014-0) / 62000 TABLET, FILM COATED in 1 BAG 1 bag 24-MAR-14 Current