oxycodone and acetaminophen

Generic: oxycodone and acetaminophen

Labeler: direct rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

acetaminophen 325 mg/1, oxycodone hydrochloride 7.5 mg/1

Manufacturer
DIRECT RX

Identifiers & Regulatory

Product NDC 72189-256
Product ID 72189-256_36d68732-0635-1380-e063-6394a90a69c6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207510
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2021-08-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189256
Hyphenated Format 72189-256

Supplemental Identifiers

RxCUI
1049214 1049225 1049621 1049683
UNII
C1ENJ2TE6C 362O9ITL9D

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 ANDA207510 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 7.5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (72189-256-30)
  • 60 TABLET in 1 BOTTLE (72189-256-60)
  • 120 TABLET in 1 BOTTLE (72189-256-72)
source: ndc

Packages (3)

72189-256-30 30 TABLET in 1 BOTTLE (72189-256-30) 72189-256-60 60 TABLET in 1 BOTTLE (72189-256-60) 72189-256-72 120 TABLET in 1 BOTTLE (72189-256-72)

Ingredients (2)

acetaminophen (325 mg/1) oxycodone hydrochloride (7.5 mg/1)

Linked Drug Pages (1)

OXYCODONE HYDROCHLORIDE, OXYCODONE AND ACETAMINOPHEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "36d68732-0635-1380-e063-6394a90a69c6", "openfda": {"unii": ["C1ENJ2TE6C", "362O9ITL9D"], "rxcui": ["1049214", "1049225", "1049621", "1049683"], "spl_set_id": ["a8206207-ad09-83df-e053-2995a90a78b7"], "manufacturer_name": ["DIRECT RX"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-256-30)", "package_ndc": "72189-256-30", "marketing_start_date": "20210810"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (72189-256-60)", "package_ndc": "72189-256-60", "marketing_start_date": "20210810"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (72189-256-72)", "package_ndc": "72189-256-72", "marketing_start_date": "20210810"}], "brand_name": "OXYCODONE AND ACETAMINOPHEN", "product_id": "72189-256_36d68732-0635-1380-e063-6394a90a69c6", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "72189-256", "dea_schedule": "CII", "generic_name": "OXYCODONE AND ACETAMINOPHEN", "labeler_name": "DIRECT RX", "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": "ANDA207510", "marketing_category": "ANDA", "marketing_start_date": "20210810", "listing_expiration_date": "20261231"}