TRIENTINE HYDROCHLORIDE
TRIENTINE HYDROCHLORIDE CAPSULES USP Rx only
Approved
Approval ID
2c0d626e-ac87-4221-8566-1381b6f07840
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 2, 2022
Manufacturers
FDA
Lannett Company Inc.
DUNS: 002277481
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 Code0527-4068
Application NumberANDA211251
Product Classification
M
Marketing Category
C73584
G
Generic Name
TRIENTINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 2, 2022
FDA Product Classification
INGREDIENTS (9)
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TRIENTINE HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: HC3NX54582
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT