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 ID71269-040_7ecc03e0-b56e-4ac0-9f91-bd245ef56f32
NDC71269-040
Product TypeHuman Prescription Drug
Proprietary NameTuxarin
Generic NameCodeine Phosphate And Chlorpheniramine Maleate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-10-15
Marketing CategoryNDA / NDA
Application NumberNDA206323
Labeler NameMainpointe Pharmaceuticals
Substance NameCODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE
Active Ingredient Strength54 mg/1; mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71269-040-10

100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-10)
Marketing Start Date2018-10-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71269-040-10 [71269004010]

Tuxarin TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA206323
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-15

Drug Details

Active Ingredients

IngredientStrength
CODEINE PHOSPHATE54.3 mg/1

OpenFDA Data

SPL SET ID:a7cfab67-6087-4ab4-b7cd-4f9295413180
Manufacturer
UNII
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]

    Trademark Results [Tuxarin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TUXARIN
    TUXARIN
    97027082 not registered Live/Pending
    MainPointe Pharmaceuticals, LLC
    2021-09-14
    TUXARIN
    TUXARIN
    86659512 not registered Dead/Abandoned
    Spriaso LLC
    2015-06-11

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