FDA.reportPublic FDA data

Trientine Hydrochloride

Product NDC
66435-700
Requested package NDC
66435-700-12
11-digit product format
664350700
Labeler code
66435
Product ID
66435-700_463a763f-bba2-49e3-a8e8-1677c3aa121b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trientine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Kadmon Pharmaceuticals, LLC
Application
ANDA209415
Marketing category
ANDA
Marketing start
2019-09-30
Marketing end
2021-09-30
Substance
TRIENTINE HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Metal Chelating Activity [MoA],Metal Chelator [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage66435-70066435-700-12DDiscontinued by firm2026-08-03

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
A209415-001TRIENTINE HYDROCHLORIDETRIENTINE HYDROCHLORIDE250MGCAPSULE / ORAL2019-09-16

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 22:54:322026-06A209415-001TRIENTINE HYDROCHLORIDE250MGCAPSULE / ORAL2019-09-16a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66435-700-10EA - Each66435-7006f26786f-59d3-44c5-9799-30185d28f30412019-10-07
66435-700-12EA - Each66435-70064b10f76-9456-4286-b3ed-aedd482709e212020-03-10
66435-700-20EA - Each66435-700b40badf1-2500-45f7-8043-4b77f408e5ae12020-03-10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66435-700-126643507001212 CAPSULE in 1 BLISTER PACK (66435-700-12) 12 capsule2019-10-212021-09-30NoNoCurrent