acetaminophen and codeine phosphate

Generic: acetaminophen and codeine phosphate

Labeler: clinical solutions wholesale, 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 clinical solutions wholesale, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Clinical Solutions Wholesale, LLC

Identifiers & Regulatory

Product NDC 58118-4484
Product ID 58118-4484_0e76cd12-9f35-c98f-e063-6394a90ad9fb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040419
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2019-02-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 581184484
Hyphenated Format 58118-4484

Supplemental Identifiers

RxCUI
993781
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
  • 30 TABLET in 1 BLISTER PACK (58118-4484-8)
source: ndc

Packages (1)

58118-4484-8 30 TABLET in 1 BLISTER PACK (58118-4484-8)

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": "0e76cd12-9f35-c98f-e063-6394a90ad9fb", "openfda": {"unii": ["362O9ITL9D", "GSL05Y1MN6"], "rxcui": ["993781"], "spl_set_id": ["331d92ac-7287-47c7-b573-b5e6cd58c981"], "manufacturer_name": ["Clinical Solutions Wholesale, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (58118-4484-8)", "package_ndc": "58118-4484-8", "marketing_start_date": "20190227"}], "brand_name": "ACETAMINOPHEN AND CODEINE PHOSPHATE", "product_id": "58118-4484_0e76cd12-9f35-c98f-e063-6394a90ad9fb", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "58118-4484", "dea_schedule": "CIII", "generic_name": "acetaminophen and codeine phosphate", "labeler_name": "Clinical Solutions Wholesale, 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": "20190227", "listing_expiration_date": "20261231"}