Home NDC 64980-450-01 Trientine hydrochloride
Product NDC 64980-450
Requested package NDC 64980-450-01
11-digit product format 649800450
Labeler code 64980
Product ID 64980-450_db938579-9a95-4fc6-98e2-46caf77b7c7b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trientine hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Rising Pharmaceuticals, Inc.
Application ANDA212238
Marketing category ANDA
Marketing start 2020-02-20
Marketing end 0000-00-00
Substance TRIENTINE HYDROCHLORIDE
Active strength 250 mg/1
Pharmacologic classes Metal Chelating Activity [MoA], Metal Chelator [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
Historic NDC status page 1 of 1 · 9 matching rows.
Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64980-450 64980-450-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64980-450 64980-450-01 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64980-450 64980-450-01 D Discontinued by firm excluded / ndc_excluded.zip 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64980-450 64980-450-01 D Discontinued by firm excluded / ndc_excluded.zip a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64980-450 64980-450-01 D Discontinued by firm excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64980-450 64980-450-01 D Discontinued by firm excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64980-450 64980-450-01 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64980-450 64980-450-01 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64980-450 64980-450-01 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212238-001 TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 A212238-002 TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE 500MG CAPSULE / ORAL RS 2023-09-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212238-001 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 · 57 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 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212238-002 TRIENTINE HYDROCHLORIDE 500MG CAPSULE / ORAL RS 2023-09-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212238-002 TRIENTINE HYDROCHLORIDE 500MG CAPSULE / ORAL 2023-09-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212238-002 TRIENTINE HYDROCHLORIDE 500MG CAPSULE / ORAL 2023-09-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212238-002 TRIENTINE HYDROCHLORIDE 500MG CAPSULE / ORAL 2023-09-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212238-002 TRIENTINE HYDROCHLORIDE 500MG CAPSULE / ORAL 2023-09-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212238-002 TRIENTINE HYDROCHLORIDE 500MG CAPSULE / ORAL 2023-09-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212238-002 TRIENTINE HYDROCHLORIDE 500MG CAPSULE / ORAL 2023-09-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212238-002 TRIENTINE HYDROCHLORIDE 500MG CAPSULE / ORAL 2023-09-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212238-002 TRIENTINE HYDROCHLORIDE 500MG CAPSULE / ORAL 2023-09-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212238-002 TRIENTINE HYDROCHLORIDE 500MG CAPSULE / ORAL 2023-09-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212238-002 TRIENTINE HYDROCHLORIDE 500MG CAPSULE / ORAL 2023-09-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212238-002 TRIENTINE HYDROCHLORIDE 500MG CAPSULE / ORAL 2023-09-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212238-002 TRIENTINE HYDROCHLORIDE 500MG CAPSULE / ORAL 2023-09-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212238-002 TRIENTINE HYDROCHLORIDE 500MG CAPSULE / ORAL 2023-09-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212238-002 TRIENTINE HYDROCHLORIDE 500MG CAPSULE / ORAL 2023-09-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212238-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2020-02-20 1c564ffb4f44…
Observed Orange Book normalized TE history# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64980-450-01 64980045001 100 CAPSULE in 1 BOTTLE (64980-450-01) 100 capsule 2020-02-20 0000-00-00 No No Current