Home NDC 0078-0937 EGATEN
Product NDC 0078-0937
11-digit product format 000780937
Labeler code 0078
Product ID 0078-0937_59dff6dc-c0b0-4f26-9738-32f8a6540033
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name triclabendazole
Dosage form TABLET
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Application NDA208711
Marketing category NDA
Marketing start 2019-02-13
Substance TRICLABENDAZOLE
Active strength 250 mg/1
Pharmacologic classes Anthelmintic [EPC], Anthelmintics [CS], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2A6 Inhibitors [MoA], Cytochrome P450 2B6 Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA]
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 1 .
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 N208711-001 EGATEN TRICLABENDAZOLE 250MG TABLET / ORAL RLD, RS 2019-02-13
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N208711-001 ODE-228 2026-02-13
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208711-001 EGATEN 250MG TABLET / ORAL RLD, RS 2019-02-13 cb3db0bc1861…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 76 observed states.
Additional Listing Data#
Finished product Yes
Brand name base EGATEN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRICLABENDAZOLE 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4784C8E03O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2118606 Internal RxNorm lookup 2118612 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 0078-0937-91 EGATEN 4 in 1 BLISTER PACK TABLET 4 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0937 EGATEN (TRICLABENDAZOLE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] 11 Current NDC, Legacy NDC, 1 package rows 20250308_5552884e-10ea-450c-9658-d3d4f33c946e.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EGATEN TRICLABENDAZOLE Novartis Pharmaceuticals Corporation 5552884e-10ea-450c-9658-d3d4f33c946e 2026-06-04 Warnings, Adverse reactions Exact identifier application applno (NDA): 208711 application number: NDA208711 ndc (product): 0078-0937
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 0078-0937-91 00078093791 4 TABLET in 1 BLISTER PACK (0078-0937-91) 4 tablet 2019-02-13 0000-00-00 No No Current