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United States · US · US:71269-040_c64324ef-f77f-4467-844a-711a6b305582

Tuxarin

Orange BookUNIISPLATC R06AB

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerMainpointe Pharmaceuticals
CountryUS (United States)
ATC codeR06AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7126904010
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-10)
  • ndc11
    7126904030
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-30)

Annotations

UNII (FDA Substance ID)
V1Q0O9OJ9Z
CHLORPHENIRAMINE MALEATE
RxCUI 142429
Orange Book
N206323
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "V1Q0O9OJ9Z",
    "rxcui": "142429",
    "inchikey": "DBAKFASWICGISY-BTJKTKAUSA-N",
    "display_name": "CHLORPHENIRAMINE MALEATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a7cfab67-6087-4ab4-b7cd-4f9295413180": {
      "match": "brand_token",
      "title": "TUXARIN (CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE) TABLET, EXTENDED RELEASE [MAINPOINTE PHARMACEUTICALS]",
      "spl_version": "6",
      "published_date": "2024-01-19"
    }
  },
  "productid": "71269-040_c64324ef-f77f-4467-844a-711a6b305582",
  "productndc": "71269-040",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "206323",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "8MG;54.3MG",
        "product_no": "001",
        "approval_date": "Jun 22, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE",
  "proprietary_name": "Tuxarin",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA206323",
  "marketing_category": "NDA",
  "nonproprietary_name": "codeine phosphate and chlorpheniramine maleate",
  "start_marketing_date": "20181015",
  "active_numerator_strength": "8; 54.3"
}

Related drugs

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