FDA.reportPublic FDA data

Trientine hydrochloride

Product NDC
69539-078
Requested package NDC
69539-078-91
11-digit product format
695390078
Labeler code
69539
Product ID
69539-078_8908d8af-fa31-4711-a33c-f4b7fbf7d31f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trientine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
MSN LABORATORIES PRIVATE LIMITED
Application
ANDA211134
Marketing category
ANDA
Marketing start
2019-05-22
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69539-07869539-078-91DDiscontinued 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
A211134-001TRIENTINE HYDROCHLORIDETRIENTINE HYDROCHLORIDE250MGCAPSULE / ORALAB2019-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211134-001AB

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 22:54:322026-06A211134-001TRIENTINE HYDROCHLORIDE250MGCAPSULE / ORALAB2019-05-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211134-001AB1a50c72e98297…

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 HYDROCHLORIDENovadoz Pharmaceuticals LLC6bc468ca-07ef-4965-b502-0330b76455a02022-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211134
application number: ANDA211134

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69539-078TRIENTINE HYDROCHLORIDE CAPSULE [MSN LABORATORIES PRIVATE LIMITED]3Legacy NDC20190529_a06303b2-ac18-41bf-82c3-881cf7ecefb2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69539-078-91695390078911 BOTTLE in 1 CARTON (69539-078-91) > 100 CAPSULE in 1 BOTTLE1 bottle2019-05-220000-00-00NoNoCurrent