Triacin-C
TRIACIN-C (Triprolidine HCl, Pseudoephedrine HCl, and Codeine Phosphate Syrup)
Approved
Approval ID
6cc01bb7-27c5-43c4-8e21-64ecbfbb4fa2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 28, 2015
Manufacturers
FDA
STI Pharma LLC
DUNS: 832714070
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54879-005
Application NumberANDA088704
Product Classification
M
Marketing Category
C73584
G
Generic Name
TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP
Product Specifications
Route of AdministrationORAL
Effective DateJuly 29, 2015
FDA Product Classification
INGREDIENTS (13)
CODEINE PHOSPHATEActive
Quantity: 10 mg in 5 mL
Code: GSL05Y1MN6
Classification: ACTIB
PSEUDOEPHEDRINE HYDROCHLORIDEActive
Quantity: 30 mg in 5 mL
Code: 6V9V2RYJ8N
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRIPROLIDINE HYDROCHLORIDEActive
Quantity: 1.25 mg in 5 mL
Code: YAN7R5L890
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
CARAMELInactive
Code: T9D99G2B1R
Classification: IACT