Trientine Hydrochloride
Trientine Hydrochloride Capsules, USP Rx only
Approved
Approval ID
89970c97-2535-4856-b155-62d195b5147c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2022
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Trientine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0591-4910
Application NumberANDA207567
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trientine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2022
FDA Product Classification
INGREDIENTS (8)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIENTINE HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: HC3NX54582
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT