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 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 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.
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 2026-08-01 22:54:32 2026-06 A211251-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-01-16 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A211251-001 AB 1 a50c72e98297…
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 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
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