FDA.reportPublic FDA data

Trientine Hydrochloride

Product NDC
68682-212
11-digit product format
686820212
Labeler code
68682
Product ID
68682-212_165de6fb-5a03-4acb-8cc2-433bc8c7cc92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
trientine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Oceanside Pharmaceutials
Application
NDA019194
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-02-09
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 productproduct68682-212DDiscontinued by firm2026-07-31
excluded packagepackage68682-21268682-212-10DDiscontinued 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
N019194-001SYPRINETRIENTINE HYDROCHLORIDE250MGCAPSULE / ORALABRLD, RS1985-11-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019194-001AB

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 22:54:322026-06N019194-001SYPRINE250MGCAPSULE / ORALABRLD, RS1985-11-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N019194-001AB1a50c72e98297…

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
SyprineTRIENTINE HYDROCHLORIDEBausch Health US LLCc34f77a7-996b-4470-b5df-d946a7fe5dbe2020-09-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 019194
application number: NDA019194

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-212-10EA - Each68682-21286d8ebb0-4eb8-4223-bc9c-e995a55c4d6712018-03-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68682-212-10686820212101 BOTTLE in 1 CARTON (68682-212-10) > 100 CAPSULE in 1 BOTTLE1 bottle2018-02-090000-00-00NoNoCurrent