acetaminophen and codeine phosphate

Generic: acetaminophen and codeine phosphate

Labeler: proficient rx lp
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 proficient rx lp
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 120 mg/5mL, codeine phosphate 12 mg/5mL

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-291
Product ID 63187-291_4a2943a5-d06e-489a-9d56-682712ca8a7e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA087508
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 1981-08-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187291
Hyphenated Format 63187-291

Supplemental Identifiers

RxCUI
993755
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 ANDA087508 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/5mL
  • 12 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (63187-291-04)
source: ndc

Packages (1)

63187-291-04 118 mL in 1 BOTTLE (63187-291-04)

Ingredients (2)

acetaminophen (120 mg/5mL) codeine phosphate (12 mg/5mL)

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": "4a2943a5-d06e-489a-9d56-682712ca8a7e", "openfda": {"unii": ["362O9ITL9D", "GSL05Y1MN6"], "rxcui": ["993755"], "spl_set_id": ["b14edc3f-4490-4ad1-ad72-185b627a033c"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (63187-291-04)", "package_ndc": "63187-291-04", "marketing_start_date": "20190101"}], "brand_name": "Acetaminophen and Codeine Phosphate", "product_id": "63187-291_4a2943a5-d06e-489a-9d56-682712ca8a7e", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "63187-291", "dea_schedule": "CV", "generic_name": "ACETAMINOPHEN and CODEINE PHOSPHATE", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acetaminophen and Codeine Phosphate", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "120 mg/5mL"}, {"name": "CODEINE PHOSPHATE", "strength": "12 mg/5mL"}], "application_number": "ANDA087508", "marketing_category": "ANDA", "marketing_start_date": "19810821", "listing_expiration_date": "20261231"}