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 72189-368
Product ID 72189-368_3230e687-2f8a-2c27-e063-6294a90a7a1e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207419
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2022-07-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189368
Hyphenated Format 72189-368

Supplemental Identifiers

RxCUI
1049225
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 ANDA207419 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 7.5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (72189-368-30)
  • 60 TABLET in 1 BOTTLE (72189-368-60)
  • 120 TABLET in 1 BOTTLE (72189-368-72)
  • 90 TABLET in 1 BOTTLE (72189-368-90)
source: ndc

Packages (4)

72189-368-30 30 TABLET in 1 BOTTLE (72189-368-30) 72189-368-60 60 TABLET in 1 BOTTLE (72189-368-60) 72189-368-72 120 TABLET in 1 BOTTLE (72189-368-72) 72189-368-90 90 TABLET in 1 BOTTLE (72189-368-90)

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": "3230e687-2f8a-2c27-e063-6294a90a7a1e", "openfda": {"unii": ["362O9ITL9D", "C1ENJ2TE6C"], "rxcui": ["1049225"], "spl_set_id": ["e4e27022-581e-ba8c-e053-2a95a90a1ae4"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-368-30)", "package_ndc": "72189-368-30", "marketing_start_date": "20220728"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (72189-368-60)", "package_ndc": "72189-368-60", "marketing_start_date": "20220728"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (72189-368-72)", "package_ndc": "72189-368-72", "marketing_start_date": "20220728"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (72189-368-90)", "package_ndc": "72189-368-90", "marketing_start_date": "20220728"}], "brand_name": "Oxycodone and Acetaminophen", "product_id": "72189-368_3230e687-2f8a-2c27-e063-6294a90a7a1e", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "72189-368", "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": "ANDA207419", "marketing_category": "ANDA", "marketing_start_date": "20220728", "listing_expiration_date": "20261231"}