Trientine Hydrochloride
Trientine Hydrochloride Capsules, USP Rx Only
Approved
Approval ID
f33c1322-f7c0-4684-afc8-8caa3f4023dc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 11, 2023
Manufacturers
FDA
Rising Pharma Holdings, Inc.
DUNS: 116880195
Products 2
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 Code16571-812
Application NumberANDA212238
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trientine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2023
FDA Product Classification
INGREDIENTS (10)
TRIENTINE HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: HC3NX54582
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
Trientine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16571-810
Application NumberANDA212238
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trientine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2023
FDA Product Classification
INGREDIENTS (10)
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TRIENTINE HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: HC3NX54582
Classification: ACTIB
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
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
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT