acetaminophen and codeine phosphate (50090-4610)

Drug Facts

Product Profile

Brand Name acetaminophen and codeine phosphate

Generic Name acetaminophen and codeine phosphate

Labeler a-s medication solutions

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-4610

Product ID 50090-4610_a18dafdc-8a81-4129-bbc4-808083c24b23

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA040419

DEA Schedule ciii

Listing Expiration 2027-12-31

Marketing Start 2001-05-31

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500904610

Hyphenated Format 50090-4610

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

10 TABLET in 1 BOTTLE (50090-4610-0)
12 TABLET in 1 BOTTLE (50090-4610-1)
15 TABLET in 1 BOTTLE (50090-4610-2)
20 TABLET in 1 BOTTLE (50090-4610-3)
30 TABLET in 1 BOTTLE (50090-4610-4)
100 TABLET in 1 BOTTLE (50090-4610-7)

source: ndc

Packages (6)

50090-4610-0 10 TABLET in 1 BOTTLE (50090-4610-0) 50090-4610-1 12 TABLET in 1 BOTTLE (50090-4610-1) 50090-4610-2 15 TABLET in 1 BOTTLE (50090-4610-2) 50090-4610-3 20 TABLET in 1 BOTTLE (50090-4610-3) 50090-4610-4 30 TABLET in 1 BOTTLE (50090-4610-4) 50090-4610-7 100 TABLET in 1 BOTTLE (50090-4610-7)

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": "a18dafdc-8a81-4129-bbc4-808083c24b23", "openfda": {"unii": ["362O9ITL9D", "GSL05Y1MN6"], "rxcui": ["993781"], "spl_set_id": ["dff53120-a609-4720-bd69-2391798c7dee"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (50090-4610-0)", "package_ndc": "50090-4610-0", "marketing_start_date": "20191015"}, {"sample": false, "description": "12 TABLET in 1 BOTTLE (50090-4610-1)", "package_ndc": "50090-4610-1", "marketing_start_date": "20191015"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (50090-4610-2)", "package_ndc": "50090-4610-2", "marketing_start_date": "20191015"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (50090-4610-3)", "package_ndc": "50090-4610-3", "marketing_start_date": "20191015"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (50090-4610-4)", "package_ndc": "50090-4610-4", "marketing_start_date": "20191015"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (50090-4610-7)", "package_ndc": "50090-4610-7", "marketing_start_date": "20191015"}], "brand_name": "ACETAMINOPHEN AND CODEINE PHOSPHATE", "product_id": "50090-4610_a18dafdc-8a81-4129-bbc4-808083c24b23", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "50090-4610", "dea_schedule": "CIII", "generic_name": "acetaminophen and codeine phosphate", "labeler_name": "A-S Medication Solutions", "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": "20010531", "listing_expiration_date": "20271231"}