oxycodone and acetaminophen (72865-114)

Drug Facts

Product Profile

Brand Name oxycodone and acetaminophen

Generic Name oxycodone and acetaminophen

Labeler xlcare pharmaceuticals, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

acetaminophen 325 mg/1, oxycodone hydrochloride 5 mg/1

Manufacturer

XLCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72865-114

Product ID 72865-114_9194f464-1cd1-44ac-8758-ae96b6643d5e

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207419

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2017-04-11

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72865114

Hyphenated Format 72865-114

Supplemental Identifiers

RxCUI

1049214 1049221 1049225 1049635

UPC

0372865113059 0372865116050 0372865113011 0372865115053 0372865115015 0372865114056 0372865116012 0372865114018

UNII

C1ENJ2TE6C 362O9ITL9D

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 oxycodone and acetaminophen (source: ndc)

Generic Name oxycodone and acetaminophen (source: ndc)

Application Number ANDA207419 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/1
5 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (72865-114-01)
500 TABLET in 1 BOTTLE (72865-114-05)

source: ndc

Packages (2)

72865-114-01 100 TABLET in 1 BOTTLE (72865-114-01) 72865-114-05 500 TABLET in 1 BOTTLE (72865-114-05)

Ingredients (2)

acetaminophen (325 mg/1) oxycodone hydrochloride (5 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": "9194f464-1cd1-44ac-8758-ae96b6643d5e", "openfda": {"upc": ["0372865113059", "0372865116050", "0372865113011", "0372865115053", "0372865115015", "0372865114056", "0372865116012", "0372865114018"], "unii": ["C1ENJ2TE6C", "362O9ITL9D"], "rxcui": ["1049214", "1049221", "1049225", "1049635"], "spl_set_id": ["7f3c6dd7-6bc8-450e-aded-997f9cf63a8f"], "manufacturer_name": ["XLCare Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (72865-114-01)", "package_ndc": "72865-114-01", "marketing_start_date": "20190315"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (72865-114-05)", "package_ndc": "72865-114-05", "marketing_start_date": "20190315"}], "brand_name": "OXYCODONE AND ACETAMINOPHEN", "product_id": "72865-114_9194f464-1cd1-44ac-8758-ae96b6643d5e", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "72865-114", "dea_schedule": "CII", "generic_name": "Oxycodone and Acetaminophen", "labeler_name": "XLCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OXYCODONE AND ACETAMINOPHEN", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "OXYCODONE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA207419", "marketing_category": "ANDA", "marketing_start_date": "20170411", "listing_expiration_date": "20261231"}