acetaminophen and codeine phosphate (67544-003)

Drug Facts

Product Profile

Brand Name acetaminophen and codeine phosphate

Generic Name acetaminophen and codeine phosphate

Labeler aphena pharma solutions - tennessee, llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 67544-003

Product ID 67544-003_c4cf2f28-c73e-4370-843e-487b7b42e077

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA040419

DEA Schedule ciii

Listing Expiration 2026-12-31

Marketing Start 2011-07-06

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67544003

Hyphenated Format 67544-003

Supplemental Identifiers

RxCUI

993770 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 ANDA040419 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

300 mg/1
60 mg/1

source: ndc

Packaging

60 TABLET in 1 BOTTLE, PLASTIC (67544-003-53)
90 TABLET in 1 BOTTLE, PLASTIC (67544-003-60)
120 TABLET in 1 BOTTLE, PLASTIC (67544-003-70)
180 TABLET in 1 BOTTLE, PLASTIC (67544-003-80)
240 TABLET in 1 BOTTLE, PLASTIC (67544-003-90)

source: ndc

Packages (5)

67544-003-53 60 TABLET in 1 BOTTLE, PLASTIC (67544-003-53) 67544-003-60 90 TABLET in 1 BOTTLE, PLASTIC (67544-003-60) 67544-003-70 120 TABLET in 1 BOTTLE, PLASTIC (67544-003-70) 67544-003-80 180 TABLET in 1 BOTTLE, PLASTIC (67544-003-80) 67544-003-90 240 TABLET in 1 BOTTLE, PLASTIC (67544-003-90)

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": "c4cf2f28-c73e-4370-843e-487b7b42e077", "openfda": {"unii": ["362O9ITL9D", "GSL05Y1MN6"], "rxcui": ["993770", "993781", "993890"], "spl_set_id": ["d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (67544-003-53)", "package_ndc": "67544-003-53", "marketing_start_date": "20110706"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (67544-003-60)", "package_ndc": "67544-003-60", "marketing_start_date": "20110706"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE, PLASTIC (67544-003-70)", "package_ndc": "67544-003-70", "marketing_start_date": "20110706"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (67544-003-80)", "package_ndc": "67544-003-80", "marketing_start_date": "20110706"}, {"sample": false, "description": "240 TABLET in 1 BOTTLE, PLASTIC (67544-003-90)", "package_ndc": "67544-003-90", "marketing_start_date": "20110706"}], "brand_name": "ACETAMINOPHEN AND CODEINE PHOSPHATE", "product_id": "67544-003_c4cf2f28-c73e-4370-843e-487b7b42e077", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "67544-003", "dea_schedule": "CIII", "generic_name": "acetaminophen and codeine phosphate", "labeler_name": "Aphena Pharma Solutions - 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": "60 mg/1"}], "application_number": "ANDA040419", "marketing_category": "ANDA", "marketing_start_date": "20110706", "listing_expiration_date": "20261231"}