Home NDC 72205-008 Trientine hydrochloride
Product NDC 72205-008
11-digit product format 722050008
Labeler code 72205
Product ID 72205-008_da623cb5-cd76-4236-87ad-212e25349fcd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trientine hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Novadoz Pharmaceuticals LLC
Application ANDA211134
Marketing category ANDA
Marketing start 2019-05-22
Substance TRIENTINE HYDROCHLORIDE
Active strength 250 mg/1
Pharmacologic classes Metal Chelating Activity [MoA], Metal Chelator [EPC]
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 A211134-001 TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-05-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211134-001 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 A211134-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2019-05-22 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 A211134-001 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 72205-008-91 Trientine hydrochloride 100 in 1 BOTTLE CAPSULE 100 2 72205-008-91 Trientine hydrochloride 1 in 1 CARTON CAPSULE 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72205-008 TRIENTINE HYDROCHLORIDE CAPSULE [NOVADOZ PHARMACEUTICALS LLC] 2 Current NDC, Legacy NDC, 2 package rows 20220617_6bc468ca-07ef-4965-b502-0330b76455a0.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 72205-008-91 72205000891 1 BOTTLE in 1 CARTON (72205-008-91) / 100 CAPSULE in 1 BOTTLE 1 bottle 2019-05-22 0000-00-00 No No Current