oxycodone and acetaminophen (0406-0523)

Drug Facts

Product Profile

Brand Name oxycodone and acetaminophen

Generic Name oxycodone hydrochloride and acetaminophen

Labeler specgx llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-0523

Product ID 0406-0523_38cc2423-8e75-4007-b224-75aa920582d7

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA040545

DEA Schedule cii

Listing Expiration 2027-12-31

Marketing Start 2004-06-30

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04060523

Hyphenated Format 0406-0523

Supplemental Identifiers

RxCUI

1049214 1049221 1049225

UPC

0304060522053 0304060523050 0304060512054

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 hydrochloride and acetaminophen (source: ndc)

Application Number ANDA040545 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/1
10 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (0406-0523-01)
500 TABLET in 1 BOTTLE (0406-0523-05)
1 TABLET in 1 BLISTER PACK (0406-0523-23)
100 TABLET in 1 BLISTER PACK (0406-0523-62)

source: ndc

Packages (4)

0406-0523-01 100 TABLET in 1 BOTTLE (0406-0523-01) 0406-0523-05 500 TABLET in 1 BOTTLE (0406-0523-05) 0406-0523-23 1 TABLET in 1 BLISTER PACK (0406-0523-23) 0406-0523-62 100 TABLET in 1 BLISTER PACK (0406-0523-62)

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": "38cc2423-8e75-4007-b224-75aa920582d7", "openfda": {"upc": ["0304060522053", "0304060523050", "0304060512054"], "unii": ["C1ENJ2TE6C", "362O9ITL9D"], "rxcui": ["1049214", "1049221", "1049225"], "spl_set_id": ["f2137f1a-b49a-40bd-97ac-cd6b36e295f4"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0406-0523-01)", "package_ndc": "0406-0523-01", "marketing_start_date": "20040630"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0406-0523-05)", "package_ndc": "0406-0523-05", "marketing_start_date": "20040630"}, {"sample": false, "description": "1 TABLET in 1 BLISTER PACK (0406-0523-23)", "package_ndc": "0406-0523-23", "marketing_start_date": "20040630"}, {"sample": false, "description": "100 TABLET in 1 BLISTER PACK (0406-0523-62)", "package_ndc": "0406-0523-62", "marketing_start_date": "20040630"}], "brand_name": "OXYCODONE AND ACETAMINOPHEN", "product_id": "0406-0523_38cc2423-8e75-4007-b224-75aa920582d7", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0406-0523", "dea_schedule": "CII", "generic_name": "oxycodone hydrochloride and acetaminophen", "labeler_name": "SpecGx 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": "ANDA040545", "marketing_category": "ANDA", "marketing_start_date": "20040630", "listing_expiration_date": "20271231"}