Home NDC 81802-001 CUVRIOR
Product NDC 81802-001
11-digit product format 818020001
Labeler code 81802
Product ID 81802-001_5a40d029-6e60-43ff-98b1-26702191766b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TRIENTINE TETRAHYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Orphalan SA
Application NDA215760
Marketing category NDA
Marketing start 2022-09-14
Substance TRIENTINE TETRAHYDROCHLORIDE
Active strength 300 mg/1
Pharmacologic classes Copper Chelating Activity [MoA], Copper Chelator [EPC], Metal Chelating Activity [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 43 .
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 N215760-001 CUVRIOR TRIENTINE TETRAHYDROCHLORIDE 300MG TABLET / ORAL RLD, RS 2022-04-28
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 N215760-001 12358861 2039-05-03 U-4262 Drug substance, Drug product 2025-09-22 N215760-001 12358862 2039-05-03 U-4262 Drug substance, Drug product 2025-09-22 N215760-001 12662445 2039-05-03 U-4262 Drug substance, Drug product 2026-07-06
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215760-001 ODE-401 2029-04-28
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 2026-09-14 22:38:34 2026-08 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215760-001 CUVRIOR 300MG TABLET / ORAL RLD, RS 2022-04-28 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 75 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215760-001 12358861 2039-05-03 U-4262 Drug substance, Drug product 2025-09-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215760-001 12358862 2039-05-03 U-4262 Drug substance, Drug product 2025-09-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215760-001 12662445 2039-05-03 U-4262 Drug substance, Drug product 2026-07-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215760-001 12358861 2039-05-03 U-4262 Drug substance, Drug product 2025-09-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215760-001 12358862 2039-05-03 U-4262 Drug substance, Drug product 2025-09-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215760-001 12662445 2039-05-03 U-4262 Drug substance, Drug product 2026-07-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215760-001 12358861 2039-05-03 U-4262 Drug substance, Drug product 2025-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215760-001 12358862 2039-05-03 U-4262 Drug substance, Drug product 2025-09-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215760-001 12358861 2039-05-03 U-4262 Drug substance, Drug product 2025-09-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215760-001 12358862 2039-05-03 U-4262 Drug substance, Drug product 2025-09-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 1e350fbaab3a…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 52 observed states.
Additional Listing Data#
Finished product Yes
Brand name base CUVRIOR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIENTINE TETRAHYDROCHLORIDE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7360URE56Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2611544 Internal RxNorm lookup 2611550 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81802-001-08 CUVRIOR 8 in 1 BLISTER PACK TABLET, FILM COATED 8 7 81802-001-08 CUVRIOR 1 in 1 CARTON TABLET, FILM COATED 1 7 81802-001-72 CUVRIOR 9 in 1 CARTON TABLET, FILM COATED 9 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81802-001 CUVRIOR (TRIENTINE TETRAHYDROCHLORIDE) TABLET, FILM COATED [ORPHALAN SA] 6 Current NDC, Legacy NDC, 3 package rows 20250306_f73feeae-62ad-401e-b9f7-5cb269127750.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.
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 81802-001-08 81802000108 8 in 1 BLISTER PACK Historical 81802-001-72 81802000172 9 CARTON in 1 CARTON (81802-001-72) / 1 BLISTER PACK in 1 CARTON (81802-001-08) / 8 TABLET, FILM COATED in 1 BLISTER PACK 9 carton 2022-09-14 0000-00-00 No No Current