acetaminophen and codeine phosphate

Generic: acetaminophen and codeine phosphate

Labeler: pai holdings, llc dba pai pharma
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 pai holdings, llc dba pai pharma
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 300 mg/12.5mL, codeine phosphate 30 mg/12.5mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-1008
Product ID 0121-1008_7cfdf5a3-ffd5-403b-8421-6275ca7cf02d
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 01211008
Hyphenated Format 0121-1008

Supplemental Identifiers

RxCUI
993755
UPC
0301210504167 0301210504044
UNII
362O9ITL9D GSL05Y1MN6

Packaging Origin

Original Packager
true

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
  • 300 mg/12.5mL
  • 30 mg/12.5mL
source: ndc
Packaging
  • 12.5 mL in 1 CUP, UNIT-DOSE (0121-1008-12)
  • 40 TRAY in 1 CASE (0121-1008-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 12.5 mL in 1 CUP, UNIT-DOSE (0121-1008-12)
source: ndc

Packages (2)

0121-1008-12 12.5 mL in 1 CUP, UNIT-DOSE (0121-1008-12) 0121-1008-40 40 TRAY in 1 CASE (0121-1008-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 12.5 mL in 1 CUP, UNIT-DOSE (0121-1008-12)

Ingredients (2)

acetaminophen (300 mg/12.5mL) codeine phosphate (30 mg/12.5mL)

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": "7cfdf5a3-ffd5-403b-8421-6275ca7cf02d", "openfda": {"upc": ["0301210504167", "0301210504044"], "unii": ["362O9ITL9D", "GSL05Y1MN6"], "rxcui": ["993755"], "spl_set_id": ["95ac6875-6b14-4cde-8efb-80704e39b8d8"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12.5 mL in 1 CUP, UNIT-DOSE (0121-1008-12)", "package_ndc": "0121-1008-12", "marketing_start_date": "20241007"}, {"sample": false, "description": "40 TRAY in 1 CASE (0121-1008-40)  / 10 CUP, UNIT-DOSE in 1 TRAY / 12.5 mL in 1 CUP, UNIT-DOSE (0121-1008-12)", "package_ndc": "0121-1008-40", "marketing_start_date": "19810821"}], "brand_name": "Acetaminophen and Codeine Phosphate", "product_id": "0121-1008_7cfdf5a3-ffd5-403b-8421-6275ca7cf02d", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0121-1008", "dea_schedule": "CV", "generic_name": "ACETAMINOPHEN and CODEINE PHOSPHATE", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acetaminophen and Codeine Phosphate", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "300 mg/12.5mL"}, {"name": "CODEINE PHOSPHATE", "strength": "30 mg/12.5mL"}], "application_number": "ANDA087508", "marketing_category": "ANDA", "marketing_start_date": "19810821", "listing_expiration_date": "20261231"}