Home NDC 68475-200 Trientine Hydrochloride
Product NDC 68475-200
11-digit product format 684750200
Labeler code 68475
Product ID 68475-200_57f9ea43-344a-4050-ab62-4087d5961767
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trientine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Navinta LLC
Application ANDA211251
Marketing category ANDA
Marketing start 2020-12-05
Substance TRIENTINE HYDROCHLORIDE
Active strength 250 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 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 A211251-001 TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211251-001 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.
Product history page 1 of 2 · 42 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 2026-08-18 06:07:40 2026-07 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Trientine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIENTINE HYDROCHLORIDE 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination HC3NX54582 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313472 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 68475-200-01 Trientine Hydrochloride 1 in 1 CARTON CAPSULE 1 7 68475-200-01 Trientine Hydrochloride 100 in 1 BOTTLE CAPSULE 100 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68475-200 TRIENTINE HYDROCHLORIDE CAPSULE [NAVINTA LLC] 7 Current NDC, Legacy NDC, 2 package rows 20250227_4c9233bd-be3d-46f0-8fa9-a17e61b1b9a8.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 68475-200-01 68475020001 1 BOTTLE in 1 CARTON (68475-200-01) / 100 CAPSULE in 1 BOTTLE 1 bottle 2020-12-05 0000-00-00 No No Current