Trientine Hydrochloride
Trientine Hydrochloride Capsules, USP Rx only
Approved
Approval ID
2cb8b940-881a-4529-92fb-fe4cad168619
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 18, 2019
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Trientine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1545
Application NumberANDA210619
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trientine
Product Specifications
Route of AdministrationORAL
Effective DateMay 18, 2019
FDA Product Classification
INGREDIENTS (15)
TRIENTINE HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: HC3NX54582
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT