FDA.reportPublic FDA data

Trientine Hydrochloride

Product NDC
0591-4910
11-digit product format
005914910
Labeler code
0591
Product ID
0591-4910_bcbb8581-a9bc-4a51-b2fd-9a059a2e6411
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trientine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA207567
Marketing category
ANDA
Marketing start
2018-02-08
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0591-4910DDiscontinued by firm2026-07-31
excluded packagepackage0591-49100591-4910-01DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207567-001TRIENTINE HYDROCHLORIDETRIENTINE HYDROCHLORIDE250MGCAPSULE / ORAL2018-02-07

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A207567-001TRIENTINE HYDROCHLORIDE250MGCAPSULE / ORAL2018-02-07a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a68ac59a-f073-3e03-cd2c-70c7eb201ed2Product name820230314

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-4910-01EA - Each0591-491067c1d30e-184c-466e-ab07-ef6401ed582312018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-4910TRIENTINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]8Legacy NDC20230329_89970c97-2535-4856-b155-62d195b5147c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-4910-0100591491001100 CAPSULE in 1 BOTTLE (0591-4910-01) 100 capsule2018-02-080000-00-00NoNoCurrent