Trientine Hydrochloride

Product NDC
68475-200
11-digit product format
684750200
Labeler code
68475
Product ID
68475-200_57f9ea43-344a-4050-ab62-4087d5961767
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trientine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Navinta LLC
Application
ANDA211251
Marketing category
ANDA
Marketing start
2020-12-05
Substance
TRIENTINE HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Copper Chelating Activity [MoA], Copper Chelator [EPC], Metal Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Trientine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIENTINE HYDROCHLORIDE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHC3NX54582
Rxcui313472

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a68ac59a-f073-3e03-cd2c-70c7eb201ed2Product name820230314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68475-200-01Trientine Hydrochloride1 in 1 CARTONCAPSULE17
68475-200-01Trientine Hydrochloride100 in 1 BOTTLECAPSULE1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68475-200TRIENTINE HYDROCHLORIDE CAPSULE [NAVINTA LLC]7Current NDC, Legacy NDC, 2 package rows20250227_4c9233bd-be3d-46f0-8fa9-a17e61b1b9a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313472trientine HCl 250 MG Oral CapsulePSN4c9233bd-be3d-46f0-8fa9-a17e61b1b9a87
313472trientine hydrochloride 250 MG Oral CapsuleSCD4c9233bd-be3d-46f0-8fa9-a17e61b1b9a87
313472trientine HCl 250 MG Oral CapsuleSY4c9233bd-be3d-46f0-8fa9-a17e61b1b9a87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68475-200-01684750200011 BOTTLE in 1 CARTON (68475-200-01) / 100 CAPSULE in 1 BOTTLE1 bottle2020-12-050000-00-00NoNoCurrent