Home NDC 43986-008 Trientine Hydrochloride
Product NDC 43986-008
11-digit product format 439860008
Labeler code 43986
Product ID 43986-008_94f98c17-b443-7d8e-e053-2a95a90a7776
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trientine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Bluepharma - Industria Farmaceutica, S.A.
Application ANDA210619
Marketing category ANDA
Marketing start 2019-06-01
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 2020-12-31
Current FDA listing Historical FDA.report record 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 A210619-001 TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL 2019-02-08
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 A210619-001 TRIENTINE HYDROCHLORIDE 250MG CAPSULE / ORAL 2019-02-08 a50c72e98297…