oxycodone and acetaminophen

Generic: oxycodone and acetaminophen

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxycodone and acetaminophen
Generic Name oxycodone and acetaminophen
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-984
Product ID 63187-984_09fe7043-1a50-4d4a-89ff-e0acc2850023
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201972
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2013-07-15

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187984
Hyphenated Format 63187-984

Supplemental Identifiers

RxCUI
1049221
UNII
362O9ITL9D C1ENJ2TE6C

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 ANDA201972 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BOTTLE (63187-984-10)
  • 12 TABLET in 1 BOTTLE (63187-984-12)
  • 15 TABLET in 1 BOTTLE (63187-984-15)
  • 30 TABLET in 1 BOTTLE (63187-984-30)
  • 60 TABLET in 1 BOTTLE (63187-984-60)
source: ndc

Packages (5)

63187-984-10 10 TABLET in 1 BOTTLE (63187-984-10) 63187-984-12 12 TABLET in 1 BOTTLE (63187-984-12) 63187-984-15 15 TABLET in 1 BOTTLE (63187-984-15) 63187-984-30 30 TABLET in 1 BOTTLE (63187-984-30) 63187-984-60 60 TABLET in 1 BOTTLE (63187-984-60)

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": "09fe7043-1a50-4d4a-89ff-e0acc2850023", "openfda": {"unii": ["362O9ITL9D", "C1ENJ2TE6C"], "rxcui": ["1049221"], "spl_set_id": ["dd4dbe5b-8d07-4a96-a78d-2f20da761dad"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (63187-984-10)", "package_ndc": "63187-984-10", "marketing_start_date": "20180201"}, {"sample": false, "description": "12 TABLET in 1 BOTTLE (63187-984-12)", "package_ndc": "63187-984-12", "marketing_start_date": "20180201"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (63187-984-15)", "package_ndc": "63187-984-15", "marketing_start_date": "20180201"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (63187-984-30)", "package_ndc": "63187-984-30", "marketing_start_date": "20180201"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (63187-984-60)", "package_ndc": "63187-984-60", "marketing_start_date": "20180201"}], "brand_name": "Oxycodone and Acetaminophen", "product_id": "63187-984_09fe7043-1a50-4d4a-89ff-e0acc2850023", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "63187-984", "dea_schedule": "CII", "generic_name": "Oxycodone and Acetaminophen", "labeler_name": "Proficient Rx LP", "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": "ANDA201972", "marketing_category": "ANDA", "marketing_start_date": "20130715", "listing_expiration_date": "20261231"}