oxycodone and acetaminophen (47781-196)

Drug Facts

Product Profile

Brand Name oxycodone and acetaminophen

Generic Name oxycodone and acetaminophen

Labeler alvogen, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Alvogen, Inc.

Identifiers & Regulatory

Product NDC 47781-196

Product ID 47781-196_61dc641a-41f6-5a0e-dc3a-8a957328a9c1

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202677

DEA Schedule cii

Listing Expiration 2027-12-31

Marketing Start 2016-03-09

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47781196

Hyphenated Format 47781-196

Supplemental Identifiers

RxCUI

1049214 1049221 1049225

UPC

0347781230012 0347781229016 0347781196011

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 ANDA202677 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/1
5 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (47781-196-01)
500 TABLET in 1 BOTTLE (47781-196-05)

source: ndc

Packages (2)

47781-196-01 100 TABLET in 1 BOTTLE (47781-196-01) 47781-196-05 500 TABLET in 1 BOTTLE (47781-196-05)

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": "61dc641a-41f6-5a0e-dc3a-8a957328a9c1", "openfda": {"upc": ["0347781230012", "0347781229016", "0347781196011"], "unii": ["C1ENJ2TE6C", "362O9ITL9D"], "rxcui": ["1049214", "1049221", "1049225"], "spl_set_id": ["900ec197-720e-5428-b526-055b7756aa4a"], "manufacturer_name": ["Alvogen, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (47781-196-01)", "package_ndc": "47781-196-01", "marketing_start_date": "20160309"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (47781-196-05)", "package_ndc": "47781-196-05", "marketing_start_date": "20160309"}], "brand_name": "Oxycodone and Acetaminophen", "product_id": "47781-196_61dc641a-41f6-5a0e-dc3a-8a957328a9c1", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "47781-196", "dea_schedule": "CII", "generic_name": "Oxycodone and Acetaminophen", "labeler_name": "Alvogen, 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": "ANDA202677", "marketing_category": "ANDA", "marketing_start_date": "20160309", "listing_expiration_date": "20271231"}