FDA.reportPublic FDA data

TRIENTINE HYDROCHLORIDE

Product NDC
0527-4068
Requested package NDC
0527-4068-37
11-digit product format
005274068
Labeler code
0527
Product ID
0527-4068_0090a2e0-927a-4284-a88b-b3c4cb7dbbdb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRIENTINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Lannett Company Inc.
Application
ANDA211251
Marketing category
ANDA
Marketing start
2020-12-22
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0527-40680527-4068-37DDiscontinued 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
A211251-001TRIENTINE HYDROCHLORIDETRIENTINE HYDROCHLORIDE250MGCAPSULE / ORALAB2019-01-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211251-001AB

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 22:54:322026-06A211251-001TRIENTINE HYDROCHLORIDE250MGCAPSULE / ORALAB2019-01-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211251-001AB1a50c72e98297…

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 HYDROCHLORIDENavinta LLC4c9233bd-be3d-46f0-8fa9-a17e61b1b9a82025-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211251
application number: ANDA211251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-4068-37EA - Each0527-4068362dadc1-9323-4140-84a5-a90783b5659912019-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-4068-37005274068371 BOTTLE in 1 CARTON (0527-4068-37) > 100 CAPSULE in 1 BOTTLE1 bottle2020-12-220000-00-00NoNoCurrent