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 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 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 2026-02-19 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 · 65 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2024-05-31 18:47 UTC 2024-05 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215760-001 10988436 2039-05-03 Drug substance 2022-05-26 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N215760-001 11072577 2039-05-03 U-3370 2022-05-26 ea1830bbd6c7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 50 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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
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