NDC 71269-040

Tuxarin

Codeine Phosphate And Chlorpheniramine Maleate

Tuxarin is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Mainpointe Pharmaceuticals. The primary component is Codeine Phosphate; Chlorpheniramine Maleate.

• Product ID: 71269-040_7ecc03e0-b56e-4ac0-9f91-bd245ef56f32
• NDC: 71269-040
• Product Type: Human Prescription Drug
• Proprietary Name: Tuxarin
• Generic Name: Codeine Phosphate And Chlorpheniramine Maleate
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2018-10-15
• Marketing Category: NDA / NDA
• Application Number: NDA206323
• Labeler Name: Mainpointe Pharmaceuticals
• Substance Name: CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE
• Active Ingredient Strength: 54 mg/1; mg/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 71269-040-10

100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-10)

• Marketing Start Date: 2018-10-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71269-040-10 [71269004010]

Tuxarin TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA206323
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-10-15

Drug Details

Active Ingredients

Ingredient	Strength
CODEINE PHOSPHATE	54.3 mg/1

OpenFDA Data

• SPL SET ID: a7cfab67-6087-4ab4-b7cd-4f9295413180
• Manufacturer:
  • Mainpointe Pharmaceuticals
• UNII:
  • GSL05Y1MN6
  • V1Q0O9OJ9Z
• RxNorm Concept Unique ID - RxCUI:
  • 1664543
  • 2099286
• UPC Code:
  • 0371269040107

Pharmacological Class

• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]
• Histamine H1 Receptor Antagonists [MoA]
• Histamine-1 Receptor Antagonist [EPC]