acetaminophen and codeine phosphate (0406-0485)

Drug Facts

Product Profile

Brand Name acetaminophen and codeine phosphate

Generic Name acetaminophen and codeine phosphate

Labeler specgx llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

acetaminophen 300 mg/1, codeine phosphate 60 mg/1

Manufacturer

SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-0485

Product ID 0406-0485_d718c5ef-69f7-4342-8ac6-772b45f6a726

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA040419

DEA Schedule ciii

Listing Expiration 2026-12-31

Marketing Start 2001-05-31

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04060485

Hyphenated Format 0406-0485

Supplemental Identifiers

RxCUI

993770 993781 993890

UPC

0304060485051 0304060484108 0304060483019

UNII

362O9ITL9D 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 acetaminophen and codeine phosphate (source: ndc)

Generic Name acetaminophen and codeine phosphate (source: ndc)

Application Number ANDA040419 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

300 mg/1
60 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (0406-0485-01)
500 TABLET in 1 BOTTLE (0406-0485-05)

source: ndc

Packages (2)

0406-0485-01 100 TABLET in 1 BOTTLE (0406-0485-01) 0406-0485-05 500 TABLET in 1 BOTTLE (0406-0485-05)

Ingredients (2)

acetaminophen (300 mg/1) codeine phosphate (60 mg/1)

Linked Drug Pages (1)

ACETAMINOPHEN AND CODEINE PHOSPHATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "d718c5ef-69f7-4342-8ac6-772b45f6a726", "openfda": {"upc": ["0304060485051", "0304060484108", "0304060483019"], "unii": ["362O9ITL9D", "GSL05Y1MN6"], "rxcui": ["993770", "993781", "993890"], "spl_set_id": ["eadc80fa-13c3-471a-a22f-6fe7e1ab290f"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0406-0485-01)", "package_ndc": "0406-0485-01", "marketing_start_date": "20010531"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0406-0485-05)", "package_ndc": "0406-0485-05", "marketing_start_date": "20010531"}], "brand_name": "ACETAMINOPHEN AND CODEINE PHOSPHATE", "product_id": "0406-0485_d718c5ef-69f7-4342-8ac6-772b45f6a726", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0406-0485", "dea_schedule": "CIII", "generic_name": "acetaminophen and codeine phosphate", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ACETAMINOPHEN AND CODEINE PHOSPHATE", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "300 mg/1"}, {"name": "CODEINE PHOSPHATE", "strength": "60 mg/1"}], "application_number": "ANDA040419", "marketing_category": "ANDA", "marketing_start_date": "20010531", "listing_expiration_date": "20261231"}