acetaminophen and codeine phosphate

Generic: acetaminophen and codeine phosphate

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen and codeine phosphate
Generic Name acetaminophen and codeine phosphate
Labeler advanced rx of tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 300 mg/1, codeine phosphate 30 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0527
Product ID 80425-0527_36989d17-3ef3-a649-e063-6294a90a784f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089805
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2025-06-02

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250527
Hyphenated Format 80425-0527

Supplemental Identifiers

RxCUI
993781 993890
UNII
362O9ITL9D GSL05Y1MN6

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 ANDA089805 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
  • 30 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (80425-0527-1)
  • 60 TABLET in 1 BOTTLE (80425-0527-2)
  • 90 TABLET in 1 BOTTLE (80425-0527-3)
source: ndc

Packages (3)

80425-0527-1 30 TABLET in 1 BOTTLE (80425-0527-1) 80425-0527-2 60 TABLET in 1 BOTTLE (80425-0527-2) 80425-0527-3 90 TABLET in 1 BOTTLE (80425-0527-3)

Ingredients (2)

acetaminophen (300 mg/1) codeine phosphate (30 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": "36989d17-3ef3-a649-e063-6294a90a784f", "openfda": {"unii": ["362O9ITL9D", "GSL05Y1MN6"], "rxcui": ["993781", "993890"], "spl_set_id": ["36988ba2-cefd-99f8-e063-6294a90aa41a"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (80425-0527-1)", "package_ndc": "80425-0527-1", "marketing_start_date": "20250602"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (80425-0527-2)", "package_ndc": "80425-0527-2", "marketing_start_date": "20250602"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (80425-0527-3)", "package_ndc": "80425-0527-3", "marketing_start_date": "20250602"}], "brand_name": "Acetaminophen and Codeine Phosphate", "product_id": "80425-0527_36989d17-3ef3-a649-e063-6294a90a784f", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "80425-0527", "dea_schedule": "CIII", "generic_name": "Acetaminophen and Codeine Phosphate", "labeler_name": "Advanced Rx of Tennessee, 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": "30 mg/1"}], "application_number": "ANDA089805", "marketing_category": "ANDA", "marketing_start_date": "20250602", "listing_expiration_date": "20261231"}