tuxarin

Generic: codeine phosphate and chlorpheniramine maleate

Labeler: mainpointe pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tuxarin
Generic Name codeine phosphate and chlorpheniramine maleate
Labeler mainpointe pharmaceuticals
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

chlorpheniramine maleate 8 mg/1, codeine phosphate 54.3 mg/1

Manufacturer
Mainpointe Pharmaceuticals

Identifiers & Regulatory

Product NDC 71269-040
Product ID 71269-040_c64324ef-f77f-4467-844a-711a6b305582
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA206323
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2018-10-15

Pharmacologic Class

Classes
full opioid agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71269040
Hyphenated Format 71269-040

Supplemental Identifiers

RxCUI
1664543 2099286
UPC
0371269040107
UNII
V1Q0O9OJ9Z GSL05Y1MN6

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tuxarin (source: ndc)
Generic Name codeine phosphate and chlorpheniramine maleate (source: ndc)
Application Number NDA206323 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
  • 54.3 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-10)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-30)
source: ndc

Packages (2)

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

Ingredients (2)

chlorpheniramine maleate (8 mg/1) codeine phosphate (54.3 mg/1)

Linked Drug Pages (1)

Tuxarin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c64324ef-f77f-4467-844a-711a6b305582", "openfda": {"upc": ["0371269040107"], "unii": ["V1Q0O9OJ9Z", "GSL05Y1MN6"], "rxcui": ["1664543", "2099286"], "spl_set_id": ["a7cfab67-6087-4ab4-b7cd-4f9295413180"], "manufacturer_name": ["Mainpointe Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-10)", "package_ndc": "71269-040-10", "marketing_start_date": "20181015"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-30)", "package_ndc": "71269-040-30", "marketing_start_date": "20181015"}], "brand_name": "Tuxarin", "product_id": "71269-040_c64324ef-f77f-4467-844a-711a6b305582", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "Opioid Agonist [EPC]"], "product_ndc": "71269-040", "dea_schedule": "CIII", "generic_name": "codeine phosphate and chlorpheniramine maleate", "labeler_name": "Mainpointe Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tuxarin", "active_ingredients": [{"name": "CHLORPHENIRAMINE MALEATE", "strength": "8 mg/1"}, {"name": "CODEINE PHOSPHATE", "strength": "54.3 mg/1"}], "application_number": "NDA206323", "marketing_category": "NDA", "marketing_start_date": "20181015", "listing_expiration_date": "20261231"}