oxycodone and acetaminophen

Generic: oxycodone and acetaminophen

Labeler: lupin pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

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 5 mg/1

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-491
Product ID 43386-491_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 43386491
Hyphenated Format 43386-491

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
  • 5 mg/1
source: ndc
Packaging
  • HOW SUPPLIED Oxycodone and Acetaminophen Tablets, USP is supplied as follows: 2.5 mg/325 mg White, round, flat face tablet debossed with "n" and "490" on one side and plain on the other side. Bottles of 100 NDC 43386-490-01 Bottles of 500 NDC 43386-490-05 Bottles of 1000 NDC 43386-490-10 5 mg/325 mg White, round, flat face tablet debossed with "n" and "491" on one side and bisect on the other side. Bottles of 100 NDC 43386-491-01 Bottles of 500 NDC 43386-491-05 Bottles of 1000 NDC 43386-491-10 7.5 mg/325 mg White, round, flat face tablet debossed with "n" and "492" on one side and plain on the other side. Bottles of 100 NDC 43386-492-01 Bottles of 500 NDC 43386-492-05 Bottles of 1000 NDC 43386-492-10 10 mg/325 mg White, round, flat face tablet debossed with "n" and "493" on one side and plain on the other side. Bottles of 100 NDC 43386-493-01 Bottles of 500 NDC 43386-493-05 Bottles of 1000 NDC 43386-493-10 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP. Store Oxycodone and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS/Information for Patients ]. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 SAP Code: 275918 Rev. 02/2024
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Oxycodone and Acetaminophen Tablets, USP CII 2.5 mg/325 mg 100 Count 2.5 mg/325 mg 1000 Count 5 mg/325 mg 100 Count 5 mg/325 mg 1000 Count 7.5 mg/325 mg 100 Count 7.5 mg/325 mg 1000 Count 10 mg/325 mg 100 Count 10 mg/325 mg 1000 Count 2.5-100 2.5-1000 5-100 5-1000 7.5-100 7.5-1000 10-100 10-1000
source: label

Packages (0)

No package records.

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": "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": [], "brand_name": "Oxycodone and Acetaminophen", "product_id": "43386-491_5e566e5f-2fef-4d70-8cfe-c24b13659b8e", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "43386-491", "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": "5 mg/1"}], "application_number": "ANDA204407", "marketing_category": "ANDA", "marketing_start_date": "20170224", "listing_expiration_date": "20261231"}