FDA.reportPublic FDA data

Trientine Hydrochloride

Product NDC
69238-1545
11-digit product format
692381545
Labeler code
69238
Product ID
69238-1545_b20d3b60-9923-4f06-9ec6-b2e5ba093d2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trientine
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA210619
Marketing category
ANDA
Marketing start
2019-02-08
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
2021-12-31
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 productproduct69238-1545DDiscontinued by firm2026-07-31
excluded packagepackage69238-154569238-1545-1DDiscontinued 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
A210619-001TRIENTINE HYDROCHLORIDETRIENTINE HYDROCHLORIDE250MGCAPSULE / ORAL2019-02-08

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A210619-001TRIENTINE HYDROCHLORIDE250MGCAPSULE / ORAL2019-02-08a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69238-1545-12026-01-14C16284748780-11030e365-5561-111a-e063-dadaa90a10e2Trientine Hydrochloride Capsules, USP Rx only
69238-1545-12024-01-30C16284748780-11030e365-5561-111a-e063-dadaa90a10e2Trientine Hydrochloride Capsules, USP Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1545-1EA - Each69238-1545e4ebdab7-1440-429d-b58d-8c085e9676eb12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1545TRIENTINE HYDROCHLORIDE (TRIENTINE) CAPSULE, GELATIN COATED [AMNEAL PHARMACEUTICALS NY LLC]5Legacy NDC20201230_2cb8b940-881a-4529-92fb-fe4cad168619.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69238-1545-169238154501100 CAPSULE, GELATIN COATED in 1 BOTTLE (69238-1545-1) 2019-02-080000-00-00NoNoCurrent