FDA.reportPublic FDA data

Trientine hydrochloride

Product NDC
70710-1203
Requested package NDC
70710-1203-1
11-digit product format
707101203
Labeler code
70710
Product ID
70710-1203_5595b9a4-aa3e-4151-9bd5-32dd502b0b79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trientine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA211554
Marketing category
ANDA
Marketing start
2019-04-29
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 packagepackage70710-120370710-1203-1DDiscontinued 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
A211554-001TRIENTINE HYDROCHLORIDETRIENTINE HYDROCHLORIDE250MGCAPSULE / ORALAB2019-04-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211554-001AB

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 22:54:322026-06A211554-001TRIENTINE HYDROCHLORIDE250MGCAPSULE / ORALAB2019-04-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211554-001AB1a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1203-1EA - Each70710-12032dba5c25-4f33-4318-b0a0-9e4dec9a97e812019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1203TRIENTINE HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]2Legacy NDC20221115_98548636-c8bc-449b-9494-86abac9f2edc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1203-1707101203011 BOTTLE in 1 CARTON (70710-1203-1) > 100 CAPSULE in 1 BOTTLE1 bottle2019-04-290000-00-00NoNoCurrent