oxycodone and acetaminophen (43386-493)

Drug Facts

Product Profile

Brand Name oxycodone and acetaminophen

Generic Name oxycodone and acetaminophen

Labeler lupin pharmaceuticals,inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-493

Product ID 43386-493_5e566e5f-2fef-4d70-8cfe-c24b13659b8e

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA204407

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2017-02-24

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43386493

Hyphenated Format 43386-493

Supplemental Identifiers

RxCUI

1049214 1049221 1049225 1049635

UPC

0343386492107 0343386491100 0343386491018

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 ANDA204407 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/1
10 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (43386-493-01)
500 TABLET in 1 BOTTLE (43386-493-05)

source: ndc

Packages (2)

43386-493-01 100 TABLET in 1 BOTTLE (43386-493-01) 43386-493-05 500 TABLET in 1 BOTTLE (43386-493-05)

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": "5e566e5f-2fef-4d70-8cfe-c24b13659b8e", "openfda": {"upc": ["0343386492107", "0343386491100", "0343386491018"], "unii": ["C1ENJ2TE6C", "362O9ITL9D"], "rxcui": ["1049214", "1049221", "1049225", "1049635"], "spl_set_id": ["916ff456-a27e-49dc-a312-274126a8c30c"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (43386-493-01)", "package_ndc": "43386-493-01", "marketing_start_date": "20170224"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (43386-493-05)", "package_ndc": "43386-493-05", "marketing_start_date": "20170224"}], "brand_name": "Oxycodone and Acetaminophen", "product_id": "43386-493_5e566e5f-2fef-4d70-8cfe-c24b13659b8e", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "43386-493", "dea_schedule": "CII", "generic_name": "Oxycodone and Acetaminophen", "labeler_name": "Lupin 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": "10 mg/1"}], "application_number": "ANDA204407", "marketing_category": "ANDA", "marketing_start_date": "20170224", "listing_expiration_date": "20261231"}