🇺🇸
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
- ndc117126904010100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-10)
- ndc11712690403030 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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