acetaminophen and codeine phosphate

Generic: acetaminophen and codeine phosphate

Labeler: northwind pharmaceuticals, 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 northwind pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Northwind Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 51655-910
Product ID 51655-910_2a33aebb-6244-c7c9-e063-6294a90a625c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211610
DEA Schedule ciii
Marketing Start 2023-06-14
Marketing End 2026-03-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51655910
Hyphenated Format 51655-910

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 ANDA211610 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
  • 30 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE, PLASTIC (51655-910-54)
source: ndc

Packages (1)

51655-910-54 15 TABLET in 1 BOTTLE, PLASTIC (51655-910-54)

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": "2a33aebb-6244-c7c9-e063-6294a90a625c", "openfda": {"unii": ["362O9ITL9D", "GSL05Y1MN6"], "rxcui": ["993781"], "spl_set_id": ["00b1097b-5d9a-5385-e063-6394a90a5399"], "manufacturer_name": ["Northwind Pharmaceuticals, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE, PLASTIC (51655-910-54)", "package_ndc": "51655-910-54", "marketing_end_date": "20260331", "marketing_start_date": "20230614"}], "brand_name": "ACETAMINOPHEN AND CODEINE PHOSPHATE", "product_id": "51655-910_2a33aebb-6244-c7c9-e063-6294a90a625c", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "51655-910", "dea_schedule": "CIII", "generic_name": "acetaminophen and codeine phosphate", "labeler_name": "Northwind Pharmaceuticals, 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": "ANDA211610", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20230614"}