NDC 54879-005

Triacin-C

Triprolidine And Pseudoephedrine Hydrochlorides And Codeine Phosphate Syrup

Triacin-C is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Sti Pharma Llc. The primary component is Triprolidine Hydrochloride; Pseudoephedrine Hydrochloride; Codeine Phosphate.

• Product ID: 54879-005_71f3d0dd-fdc0-4aed-9026-00ef91276ce0
• NDC: 54879-005
• Product Type: Human Prescription Drug
• Proprietary Name: Triacin-C
• Generic Name: Triprolidine And Pseudoephedrine Hydrochlorides And Codeine Phosphate Syrup
• Dosage Form: Syrup
• Route of Administration: ORAL
• Marketing Start Date: 2013-01-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA088704
• Labeler Name: STI Pharma LLC
• Substance Name: TRIPROLIDINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE
• Active Ingredient Strength: 1 mg/5mL; mg/5mL; mg/5mL
• Pharm 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

Packaging

NDC 54879-005-16

473 mL in 1 BOTTLE, PLASTIC (54879-005-16)

• Marketing Start Date: 2013-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54879-005-16 [54879000516]

Triacin-C SYRUP

• Marketing Category: ANDA
• Application Number: ANDA088704
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-01-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
TRIPROLIDINE HYDROCHLORIDE	1.25 mg/5mL

OpenFDA Data

• SPL SET ID: 6cc01bb7-27c5-43c4-8e21-64ecbfbb4fa2
• Manufacturer:
  • STI Pharma LLC
• UNII:
  • 6V9V2RYJ8N
  • GSL05Y1MN6
  • YAN7R5L890
• RxNorm Concept Unique ID - RxCUI:
  • 996650
  • 996640

Pharmacological Class

• Adrenergic alpha-Agonists [MoA]
• alpha-Adrenergic Agonist [EPC]
• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]