FDA.reportPublic FDA data

Trientine hydrochloride

Product NDC
64980-450
11-digit product format
649800450
Labeler code
64980
Product ID
64980-450_db938579-9a95-4fc6-98e2-46caf77b7c7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trientine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharmaceuticals, Inc.
Application
ANDA212238
Marketing category
ANDA
Marketing start
2020-02-20
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
2023-12-31
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 productproduct64980-450DDiscontinued by firm2026-07-31
excluded packagepackage64980-45064980-450-01DDiscontinued 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212238-001TRIENTINE HYDROCHLORIDETRIENTINE HYDROCHLORIDE250MGCAPSULE / ORALAB2020-02-20
A212238-002TRIENTINE HYDROCHLORIDETRIENTINE HYDROCHLORIDE500MGCAPSULE / ORALRS2023-09-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A212238-001AB

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 22:54:322026-06A212238-001TRIENTINE HYDROCHLORIDE250MGCAPSULE / ORALAB2020-02-20a50c72e98297…
2026-08-01 22:54:322026-06A212238-002TRIENTINE HYDROCHLORIDE500MGCAPSULE / ORALRS2023-09-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A212238-001AB1a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trientine HydrochlorideTRIENTINE HYDROCHLORIDERising Pharma Holdings, Inc.f33c1322-f7c0-4684-afc8-8caa3f4023dc2025-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212238
application number: ANDA212238

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-450-01EA - Each64980-450a3c9d7a7-2874-4c1c-b193-fcff15faf1f412020-05-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-450-0164980045001100 CAPSULE in 1 BOTTLE (64980-450-01) 100 capsule2020-02-200000-00-00NoNoCurrent