Trientine Hydrochloride

Product NDC
49884-060
11-digit product format
498840060
Labeler code
49884
Product ID
49884-060_c630e57d-26e9-4670-9d3d-fa574857f752
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trientine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA210096
Marketing category
ANDA
Marketing start
2019-09-27
Marketing end
2027-05-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Trientine Hydrochloride

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
a68ac59a-f073-3e03-cd2c-70c7eb201ed2Product name820230314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-060-01Trientine Hydrochloride100 in 1 BOTTLECAPSULE10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-060-01EA - Each49884-060477ac2a9-14e2-45e9-9fa9-a0ad99b04eac12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-060TRIENTINE HYDROCHLORIDE CAPSULE [ENDO USA, INC.]9Current NDC, Legacy NDC, 1 package rows20250109_431c7f66-d58b-4eb0-b195-d164788f9acf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313472trientine HCl 250 MG Oral CapsulePSN431c7f66-d58b-4eb0-b195-d164788f9acf10
313472trientine hydrochloride 250 MG Oral CapsuleSCD431c7f66-d58b-4eb0-b195-d164788f9acf10
313472trientine HCl 250 MG Oral CapsuleSY431c7f66-d58b-4eb0-b195-d164788f9acf10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-060-0149884006001100 CAPSULE in 1 BOTTLE (49884-060-01) 100 capsule2019-09-272027-05-31NoNoCurrent