Trientine Hydrochloride

Product NDC
43598-459
11-digit product format
435980459
Labeler code
43598
Product ID
43598-459_bdfcecdc-5523-2091-0405-62d51c91e287
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trientine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Dr.Reddys Laboratories Inc
Application
ANDA211076
Marketing category
ANDA
Marketing start
2019-07-03
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
43598-459-01Trientine Hydrochloride100 in 1 BOTTLECAPSULE1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-459-01EA - Each43598-45965c1386c-ce67-4811-83d6-087651aed5c812020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-459TRIENTINE HYDROCHLORIDE CAPSULE [DR.REDDYS LABORATORIES INC]5Current NDC, Legacy NDC, 1 package rows20241222_fff41159-af99-94bf-4327-8a6a7ee77b36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313472trientine HCl 250 MG Oral CapsulePSNfff41159-af99-94bf-4327-8a6a7ee77b365
313472trientine hydrochloride 250 MG Oral CapsuleSCDfff41159-af99-94bf-4327-8a6a7ee77b365
313472trientine HCl 250 MG Oral CapsuleSYfff41159-af99-94bf-4327-8a6a7ee77b365

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-459-0143598045901100 CAPSULE in 1 BOTTLE (43598-459-01) 100 capsule2019-07-030000-00-00NoNoCurrent