oxycodone and acetaminophen (35356-801)

Drug Facts

Product Profile

Brand Name oxycodone and acetaminophen

Generic Name oxycodone and acetaminophen

Labeler quality care products, llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

acetaminophen 325 mg/1, oxycodone hydrochloride 10 mg/1

Manufacturer

Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 35356-801

Product ID 35356-801_378ca952-250f-4c56-a263-d6925c341dd6

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202677

DEA Schedule cii

Marketing Start 2012-08-02

Marketing End 2026-04-30

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 35356801

Hyphenated Format 35356-801

Supplemental Identifiers

RxCUI

1049214 1049225

UNII

362O9ITL9D C1ENJ2TE6C

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 oxycodone and acetaminophen (source: ndc)

Generic Name oxycodone and acetaminophen (source: ndc)

Application Number ANDA202677 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/1
10 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE (35356-801-30)
60 TABLET in 1 BOTTLE (35356-801-60)
90 TABLET in 1 BOTTLE (35356-801-90)

source: ndc

Packages (3)

35356-801-30 30 TABLET in 1 BOTTLE (35356-801-30) 35356-801-60 60 TABLET in 1 BOTTLE (35356-801-60) 35356-801-90 90 TABLET in 1 BOTTLE (35356-801-90)

Ingredients (2)

acetaminophen (325 mg/1) oxycodone hydrochloride (10 mg/1)

Linked Drug Pages (1)

Oxycodone and Acetaminophen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "378ca952-250f-4c56-a263-d6925c341dd6", "openfda": {"unii": ["362O9ITL9D", "C1ENJ2TE6C"], "rxcui": ["1049214", "1049225"], "spl_set_id": ["bbbc5dc1-5a91-4430-adcb-a5f6963cc0a2"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (35356-801-30)", "package_ndc": "35356-801-30", "marketing_end_date": "20260430", "marketing_start_date": "20130910"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (35356-801-60)", "package_ndc": "35356-801-60", "marketing_end_date": "20260430", "marketing_start_date": "20130910"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (35356-801-90)", "package_ndc": "35356-801-90", "marketing_end_date": "20260430", "marketing_start_date": "20130910"}], "brand_name": "Oxycodone and Acetaminophen", "product_id": "35356-801_378ca952-250f-4c56-a263-d6925c341dd6", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "35356-801", "dea_schedule": "CII", "generic_name": "Oxycodone and Acetaminophen", "labeler_name": "Quality Care Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxycodone and Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "OXYCODONE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA202677", "marketing_category": "ANDA", "marketing_end_date": "20260430", "marketing_start_date": "20120802"}