NDC 69654-480

TUZISTRA XR

Codeine Polistirex And Chlorpheniramine Polistirex

TUZISTRA XR is a Oral Suspension, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Aytu Bioscience, Inc.. The primary component is Codeine Phosphate Anhydrous; Chlorpheniramine Maleate.

• Product ID: 69654-480_5ed55b06-3b1e-4f9a-a3f8-7f8ff9dfa9ad
• NDC: 69654-480
• Product Type: Human Prescription Drug
• Proprietary Name: TUZISTRA XR
• Generic Name: Codeine Polistirex And Chlorpheniramine Polistirex
• Dosage Form: Suspension, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2015-05-31
• Marketing Category: NDA / NDA
• Application Number: NDA207768
• Labeler Name: Aytu Bioscience, Inc.
• Substance Name: CODEINE PHOSPHATE ANHYDROUS; CHLORPHENIRAMINE MALEATE
• Active Ingredient Strength: 15 mg/5mL; mg/5mL
• Pharm Classes: Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69654-480-01

473 mL in 1 BOTTLE (69654-480-01)

• Marketing Start Date: 2018-11-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69654-480-02 [69654048002]

TUZISTRA XR SUSPENSION, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA207768
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-11-26

NDC 69654-480-01 [69654048001]

TUZISTRA XR SUSPENSION, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA207768
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-11-26

Drug Details

Active Ingredients

Ingredient	Strength
CODEINE PHOSPHATE ANHYDROUS	14.7 mg/5mL

OpenFDA Data

• SPL SET ID: b735c239-d335-4320-b31d-ae56a4d0fcdb
• Manufacturer:
  • Aytu Bioscience, Inc.
• UNII:
  • V1Q0O9OJ9Z
  • 2X585M1M3T
• RxNorm Concept Unique ID - RxCUI:
  • 1652093
  • 1652087
• UPC Code:
  • 0369654480010

Pharmacological Class

• Histamine H1 Receptor Antagonists [MoA]
• Histamine-1 Receptor Antagonist [EPC]
• Histamine H1 Receptor Antagonists [MoA]
• Histamine-1 Receptor Antagonist [EPC]

NDC Crossover Matching brand name "TUZISTRA XR" or generic name "Codeine Polistirex And Chlorpheniramine Polistirex"

NDC	Brand Name	Generic Name
69442-480	TUZISTRA XR	codeine polistirex and chlorpheniramine polistirex
69654-480	TUZISTRA XR	codeine polistirex and chlorpheniramine polistirex