OXYCODONE AND ACETAMINOPHEN

Generic: oxycodone hydrochloride and acetaminophen

Labeler: Quality Care Products, LLC
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive

Drug Facts

Product Profile

Brand Name OXYCODONE AND ACETAMINOPHEN
Generic Name oxycodone hydrochloride and acetaminophen
Labeler Quality Care Products, LLC
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ACETAMINOPHEN 325 mg/1, OXYCODONE HYDROCHLORIDE 7.5 mg/1

Identifiers & Regulatory

Product NDC 55700-984
Product ID 55700-984_fdd71f8f-45de-44a3-8ccf-c9b9e42036bd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040545
DEA Schedule CII
Marketing Start 2022-09-28
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55700984
Hyphenated Format 55700-984

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
  • 7.5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (55700-984-30)
  • 60 TABLET in 1 BOTTLE (55700-984-60)
  • 90 TABLET in 1 BOTTLE (55700-984-90)
source: ndc

Packages (3)

55700-984-30 30 TABLET in 1 BOTTLE (55700-984-30) 55700-984-60 60 TABLET in 1 BOTTLE (55700-984-60) 55700-984-90 90 TABLET in 1 BOTTLE (55700-984-90)

Ingredients (2)

ACETAMINOPHEN (325 mg/1) OXYCODONE HYDROCHLORIDE (7.5 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": "fdd71f8f-45de-44a3-8ccf-c9b9e42036bd", "openfda": {"unii": ["362O9ITL9D", "C1ENJ2TE6C"], "rxcui": ["1049225"], "spl_set_id": ["c33734a7-2abb-47f3-abeb-041a2c033225"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (55700-984-30)", "package_ndc": "55700-984-30", "marketing_end_date": "20260228", "marketing_start_date": "20220928"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (55700-984-60)", "package_ndc": "55700-984-60", "marketing_end_date": "20260228", "marketing_start_date": "20220928"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (55700-984-90)", "package_ndc": "55700-984-90", "marketing_end_date": "20260228", "marketing_start_date": "20220928"}], "brand_name": "OXYCODONE AND ACETAMINOPHEN", "product_id": "55700-984_fdd71f8f-45de-44a3-8ccf-c9b9e42036bd", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "55700-984", "dea_schedule": "CII", "generic_name": "oxycodone hydrochloride and acetaminophen", "labeler_name": "Quality Care Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OXYCODONE AND ACETAMINOPHEN", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "OXYCODONE HYDROCHLORIDE", "strength": "7.5 mg/1"}], "application_number": "ANDA040545", "marketing_category": "ANDA", "marketing_end_date": "20260228", "marketing_start_date": "20220928"}