oxycodone and acetaminophen (13107-046)

Drug Facts

Product Profile

Brand Name oxycodone and acetaminophen

Generic Name oxycodone and acetaminophen

Labeler aurolife pharma, llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Aurolife Pharma, LLC

Identifiers & Regulatory

Product NDC 13107-046

Product ID 13107-046_c86ebd1a-f32c-4a67-9a1b-ff0a3861c124

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA201972

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2013-07-15

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13107046

Hyphenated Format 13107-046

Supplemental Identifiers

RxCUI

1049214 1049221 1049225 1049635

UPC

0313107046018

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 ANDA201972 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/1
10 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (13107-046-01)
500 TABLET in 1 BOTTLE (13107-046-05)
30 TABLET in 1 BOTTLE (13107-046-30)
1000 TABLET in 1 BOTTLE (13107-046-99)

source: ndc

Packages (4)

13107-046-01 100 TABLET in 1 BOTTLE (13107-046-01) 13107-046-05 500 TABLET in 1 BOTTLE (13107-046-05) 13107-046-30 30 TABLET in 1 BOTTLE (13107-046-30) 13107-046-99 1000 TABLET in 1 BOTTLE (13107-046-99)

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": "c86ebd1a-f32c-4a67-9a1b-ff0a3861c124", "openfda": {"upc": ["0313107046018"], "unii": ["C1ENJ2TE6C", "362O9ITL9D"], "rxcui": ["1049214", "1049221", "1049225", "1049635"], "spl_set_id": ["69df20d9-b1d5-47dc-9ff0-29987284f8c7"], "manufacturer_name": ["Aurolife Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (13107-046-01)", "package_ndc": "13107-046-01", "marketing_start_date": "20130715"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (13107-046-05)", "package_ndc": "13107-046-05", "marketing_start_date": "20130715"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (13107-046-30)", "package_ndc": "13107-046-30", "marketing_start_date": "20130715"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (13107-046-99)", "package_ndc": "13107-046-99", "marketing_start_date": "20130715"}], "brand_name": "Oxycodone and Acetaminophen", "product_id": "13107-046_c86ebd1a-f32c-4a67-9a1b-ff0a3861c124", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "13107-046", "dea_schedule": "CII", "generic_name": "Oxycodone and Acetaminophen", "labeler_name": "Aurolife Pharma, 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": "ANDA201972", "marketing_category": "ANDA", "marketing_start_date": "20130715", "listing_expiration_date": "20261231"}