Triacin-C

Product NDC
54879-005
11-digit product format
548790005
Labeler code
54879
Product ID
54879-005_71f3d0dd-fdc0-4aed-9026-00ef91276ce0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP
Dosage form
SYRUP
Route
ORAL
Labeler
STI Pharma LLC
Application
ANDA088704
Marketing category
ANDA
Marketing start
2013-01-01
Marketing end
0000-00-00
Substance
TRIPROLIDINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE
Active strength
1 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CV
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
e9576821-a971-5261-628e-82ad9e10acdbProduct name220150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54879-005-162020-01-31C16284748780-19d75b9cf-ee8e-f424-e053-dadaa90a57ceTRIACIN-C (Triprolidine HCl, Pseudoephedrine HCl, and Codeine Phosphate Syrup)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54879-005-16Triacin-C473 mL in 1 BOTTLE, PLASTICSYRUP4734

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6TRIACIN-C (TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP) SYRUP [STI PHARMA LLC]4
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NTRIACIN-C (TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP) SYRUP [STI PHARMA LLC]4
TRIPROLIDINE HYDROCHLORIDEACTIVE INGREDIENTYAN7R5L890TRIACIN-C (TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP) SYRUP [STI PHARMA LLC]4
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JTRIACIN-C (TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP) SYRUP [STI PHARMA LLC]4
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FTRIACIN-C (TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP) SYRUP [STI PHARMA LLC]4
TRIPROLIDINEACTIVE MOIETY2L8T9S52QMTRIACIN-C (TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP) SYRUP [STI PHARMA LLC]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MTRIACIN-C (TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP) SYRUP [STI PHARMA LLC]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTRIACIN-C (TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP) SYRUP [STI PHARMA LLC]4
CARAMELINACTIVE INGREDIENTT9D99G2B1RTRIACIN-C (TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP) SYRUP [STI PHARMA LLC]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTRIACIN-C (TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP) SYRUP [STI PHARMA LLC]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTRIACIN-C (TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP) SYRUP [STI PHARMA LLC]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTRIACIN-C (TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP) SYRUP [STI PHARMA LLC]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTRIACIN-C (TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP) SYRUP [STI PHARMA LLC]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTRIACIN-C (TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP) SYRUP [STI PHARMA LLC]4
SORBITOLINACTIVE INGREDIENT506T60A25RTRIACIN-C (TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP) SYRUP [STI PHARMA LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RTRIACIN-C (TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP) SYRUP [STI PHARMA LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54879-005TRIACIN-C (TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP) SYRUP [STI PHARMA LLC]4Legacy NDC, 1 package rows20150730_6cc01bb7-27c5-43c4-8e21-64ecbfbb4fa2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996650codeine phosphate 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML / triprolidine hydrochloride 0.25 MG/ML Oral Solution [Triacin C]SBD6cc01bb7-27c5-43c4-8e21-64ecbfbb4fa24
996640codeine phosphate 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML / triprolidine hydrochloride 0.25 MG/ML Oral SolutionSCD6cc01bb7-27c5-43c4-8e21-64ecbfbb4fa24
996640codeine phosphate 10 MG / pseudoephedrine HCl 30 MG / triprolidine HCl 1.25 MG per 5 ML Oral SolutionSY6cc01bb7-27c5-43c4-8e21-64ecbfbb4fa24
996650Triacin C (codeine phosphate 10 MG / pseudoephedrine HCl 30 MG / triprolidine HCl 1.25 MG) per 5 ML Oral SolutionSY6cc01bb7-27c5-43c4-8e21-64ecbfbb4fa24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
54879-005-1654879000516473 mL in 1 BOTTLE, PLASTIC473 mlHistorical