Home NDC 62332-478 ENTACAPONE
Product NDC 62332-478
11-digit product format 623320478
Labeler code 62332
Product ID 62332-478_1f593c6e-e832-4668-89fa-46904f7f5f8e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ENTACAPONE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Alembic Pharmaceuticals Inc.
Application ANDA212601
Marketing category ANDA
Marketing start 2022-01-06
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 A212601-001 ENTACAPONE ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212601-001 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.
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 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212601-001 ENTACAPONE 200MG TABLET / ORAL AB 2022-01-04 a50c72e98297…
Observed Orange Book normalized TE history# 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 62332-478-31 ENTACAPONE 100 in 1 BOTTLE TABLET, FILM COATED 100 3 62332-478-91 ENTACAPONE 1000 in 1 BOTTLE TABLET, FILM COATED 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62332-478 ENTACAPONE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.] 3 Current NDC, Legacy NDC, 2 package rows 20220110_a3782792-75c4-418d-be96-9071df475748.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 · 2 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 62332-478-31 62332047831 100 TABLET, FILM COATED in 1 BOTTLE (62332-478-31) 2022-01-06 0000-00-00 No No Current 62332-478-91 62332047891 1000 TABLET, FILM COATED in 1 BOTTLE (62332-478-91) 2022-01-06 0000-00-00 No No Current