Home NDC 49884-060 Trientine Hydrochloride
Product NDC 49884-060
11-digit product format 498840060
Labeler code 49884
Product ID 49884-060_c630e57d-26e9-4670-9d3d-fa574857f752
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trientine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Par Health USA, LLC
Application ANDA210096
Marketing category ANDA
Marketing start 2019-09-27
Marketing end 2027-05-31
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
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 A210096-001 TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL 2019-09-25
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 A210096-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL 2019-09-25 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 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 49884-060-01 Trientine Hydrochloride 100 in 1 BOTTLE CAPSULE 100 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49884-060 TRIENTINE HYDROCHLORIDE CAPSULE [ENDO USA, INC.] 9 Current NDC, Legacy NDC, 1 package rows 20250109_431c7f66-d58b-4eb0-b195-d164788f9acf.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 49884-060-01 49884006001 100 CAPSULE in 1 BOTTLE (49884-060-01) 100 capsule 2019-09-27 2027-05-31 No No Current