acetaminophen and codeine phosphate

Generic: acetaminophen and codeine phosphate

Labeler: aphena pharma solutions - 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 aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 67544-002
Product ID 67544-002_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 67544002
Hyphenated Format 67544-002

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
  • 30 mg/1
source: ndc
Packaging
  • 9 TABLET in 1 BOTTLE, PLASTIC (67544-002-09)
  • 15 TABLET in 1 BOTTLE, PLASTIC (67544-002-15)
  • 20 TABLET in 1 BOTTLE, PLASTIC (67544-002-20)
  • 30 TABLET in 1 BOTTLE, PLASTIC (67544-002-30)
  • 40 TABLET in 1 BOTTLE, PLASTIC (67544-002-40)
  • 45 TABLET in 1 BOTTLE, PLASTIC (67544-002-45)
  • 56 TABLET in 1 BOTTLE, PLASTIC (67544-002-46)
  • 50 TABLET in 1 BOTTLE, PLASTIC (67544-002-50)
  • 60 TABLET in 1 BOTTLE, PLASTIC (67544-002-53)
  • 84 TABLET in 1 BOTTLE, PLASTIC (67544-002-54)
  • 75 TABLET in 1 BOTTLE, PLASTIC (67544-002-55)
  • 90 TABLET in 1 BOTTLE, PLASTIC (67544-002-60)
  • 120 TABLET in 1 BOTTLE, PLASTIC (67544-002-70)
  • 112 TABLET in 1 BOTTLE, PLASTIC (67544-002-72)
  • 150 TABLET in 1 BOTTLE, PLASTIC (67544-002-75)
  • 180 TABLET in 1 BOTTLE, PLASTIC (67544-002-80)
  • 200 TABLET in 1 BOTTLE, PLASTIC (67544-002-85)
  • 240 TABLET in 1 BOTTLE, PLASTIC (67544-002-90)
  • 300 TABLET in 1 BOTTLE, PLASTIC (67544-002-93)
source: ndc

Packages (19)

67544-002-09 9 TABLET in 1 BOTTLE, PLASTIC (67544-002-09) 67544-002-15 15 TABLET in 1 BOTTLE, PLASTIC (67544-002-15) 67544-002-20 20 TABLET in 1 BOTTLE, PLASTIC (67544-002-20) 67544-002-30 30 TABLET in 1 BOTTLE, PLASTIC (67544-002-30) 67544-002-40 40 TABLET in 1 BOTTLE, PLASTIC (67544-002-40) 67544-002-45 45 TABLET in 1 BOTTLE, PLASTIC (67544-002-45) 67544-002-46 56 TABLET in 1 BOTTLE, PLASTIC (67544-002-46) 67544-002-50 50 TABLET in 1 BOTTLE, PLASTIC (67544-002-50) 67544-002-53 60 TABLET in 1 BOTTLE, PLASTIC (67544-002-53) 67544-002-54 84 TABLET in 1 BOTTLE, PLASTIC (67544-002-54) 67544-002-55 75 TABLET in 1 BOTTLE, PLASTIC (67544-002-55) 67544-002-60 90 TABLET in 1 BOTTLE, PLASTIC (67544-002-60) 67544-002-70 120 TABLET in 1 BOTTLE, PLASTIC (67544-002-70) 67544-002-72 112 TABLET in 1 BOTTLE, PLASTIC (67544-002-72) 67544-002-75 150 TABLET in 1 BOTTLE, PLASTIC (67544-002-75) 67544-002-80 180 TABLET in 1 BOTTLE, PLASTIC (67544-002-80) 67544-002-85 200 TABLET in 1 BOTTLE, PLASTIC (67544-002-85) 67544-002-90 240 TABLET in 1 BOTTLE, PLASTIC (67544-002-90) 67544-002-93 300 TABLET in 1 BOTTLE, PLASTIC (67544-002-93)

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": "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": "9 TABLET in 1 BOTTLE, PLASTIC (67544-002-09)", "package_ndc": "67544-002-09", "marketing_start_date": "20110706"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE, PLASTIC (67544-002-15)", "package_ndc": "67544-002-15", "marketing_start_date": "20110706"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (67544-002-20)", "package_ndc": "67544-002-20", "marketing_start_date": "20110706"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (67544-002-30)", "package_ndc": "67544-002-30", "marketing_start_date": "20110706"}, {"sample": false, "description": "40 TABLET in 1 BOTTLE, PLASTIC (67544-002-40)", "package_ndc": "67544-002-40", "marketing_start_date": "20110706"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE, PLASTIC (67544-002-45)", "package_ndc": "67544-002-45", "marketing_start_date": "20110706"}, {"sample": false, "description": "56 TABLET in 1 BOTTLE, PLASTIC (67544-002-46)", "package_ndc": "67544-002-46", "marketing_start_date": "20210728"}, {"sample": false, "description": "50 TABLET in 1 BOTTLE, PLASTIC (67544-002-50)", "package_ndc": "67544-002-50", "marketing_start_date": "20110706"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (67544-002-53)", "package_ndc": "67544-002-53", "marketing_start_date": "20110706"}, {"sample": false, "description": "84 TABLET in 1 BOTTLE, PLASTIC (67544-002-54)", "package_ndc": "67544-002-54", "marketing_start_date": "20210804"}, {"sample": false, "description": "75 TABLET in 1 BOTTLE, PLASTIC (67544-002-55)", "package_ndc": "67544-002-55", "marketing_start_date": "20110706"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (67544-002-60)", "package_ndc": "67544-002-60", "marketing_start_date": "20110706"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE, PLASTIC (67544-002-70)", "package_ndc": "67544-002-70", "marketing_start_date": "20110706"}, {"sample": false, "description": "112 TABLET in 1 BOTTLE, PLASTIC (67544-002-72)", "package_ndc": "67544-002-72", "marketing_start_date": "20210810"}, {"sample": false, "description": "150 TABLET in 1 BOTTLE, PLASTIC (67544-002-75)", "package_ndc": "67544-002-75", "marketing_start_date": "20110706"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (67544-002-80)", "package_ndc": "67544-002-80", "marketing_start_date": "20110706"}, {"sample": false, "description": "200 TABLET in 1 BOTTLE, PLASTIC (67544-002-85)", "package_ndc": "67544-002-85", "marketing_start_date": "20110706"}, {"sample": false, "description": "240 TABLET in 1 BOTTLE, PLASTIC (67544-002-90)", "package_ndc": "67544-002-90", "marketing_start_date": "20110706"}, {"sample": false, "description": "300 TABLET in 1 BOTTLE, PLASTIC (67544-002-93)", "package_ndc": "67544-002-93", "marketing_start_date": "20110706"}], "brand_name": "ACETAMINOPHEN AND CODEINE PHOSPHATE", "product_id": "67544-002_c4cf2f28-c73e-4370-843e-487b7b42e077", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "67544-002", "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": "30 mg/1"}], "application_number": "ANDA040419", "marketing_category": "ANDA", "marketing_start_date": "20110706", "listing_expiration_date": "20261231"}