Home NDC 68682-212 Trientine Hydrochloride
Product NDC 68682-212
11-digit product format 686820212
Labeler code 68682
Product ID 68682-212_165de6fb-5a03-4acb-8cc2-433bc8c7cc92
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name trientine hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Oceanside Pharmaceutials
Application NDA019194
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2018-02-09
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 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68682-212-10 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68682-212-10 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68682-212-10 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68682-212-10 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68682-212-10 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68682-212-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68682-212-10 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68682-212-10 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68682-212-10 0efc9e666f02…f202fb6c5f17…
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 N019194-001 SYPRINE TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019194-001 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 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019194-001 SYPRINE 250MG CAPSULE / ORAL AB RLD, RS 1985-11-08 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 Syprine TRIENTINE HYDROCHLORIDE Bausch Health US LLC c34f77a7-996b-4470-b5df-d946a7fe5dbe 2020-09-01 Warnings, Adverse reactions Exact identifier application applno (NDA): 019194 application number: NDA019194
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68682-212-10 68682021210 1 BOTTLE in 1 CARTON (68682-212-10) > 100 CAPSULE in 1 BOTTLE 1 bottle 2018-02-09 0000-00-00 No No Current