Trientine Hydrochloride

Product NDC
16571-812
11-digit product format
165710812
Labeler code
16571
Product ID
16571-812_96619f61-e1f2-4ed3-9a81-c05077c8cbcb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trientine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA212238
Marketing category
ANDA
Marketing start
2023-09-22
Substance
TRIENTINE HYDROCHLORIDE
Active strength
500 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 HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHC3NX54582
Rxcui313472, 2619912

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
16571-812-05Trientine Hydrochloride50 in 1 BOTTLECAPSULE506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-812-05EA - Each16571-812d24fefeb-1216-40a7-aa20-7d8e830ee54012023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-812TRIENTINE HYDROCHLORIDE CAPSULE [RISING PHARMA HOLDINGS, INC.]5Current NDC, Legacy NDC, 1 package rows20230926_f33c1322-f7c0-4684-afc8-8caa3f4023dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313472trientine HCl 250 MG Oral CapsulePSNf33c1322-f7c0-4684-afc8-8caa3f4023dc6
2619912trientine HCl 500 MG Oral CapsulePSNf33c1322-f7c0-4684-afc8-8caa3f4023dc6
313472trientine hydrochloride 250 MG Oral CapsuleSCDf33c1322-f7c0-4684-afc8-8caa3f4023dc6
2619912trientine hydrochloride 500 MG Oral CapsuleSCDf33c1322-f7c0-4684-afc8-8caa3f4023dc6
313472trientine HCl 250 MG Oral CapsuleSYf33c1322-f7c0-4684-afc8-8caa3f4023dc6
2619912trientine HCl 500 MG Oral CapsuleSYf33c1322-f7c0-4684-afc8-8caa3f4023dc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-812-051657108120550 CAPSULE in 1 BOTTLE (16571-812-05) 50 capsule2023-09-220000-00-00NoNoCurrent