oxycodone/apap

Generic: oxycodone/apap

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxycodone/apap
Generic Name oxycodone/apap
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 72189-375
Product ID 72189-375_4c4c55ca-eef7-8b39-e063-6294a90adf3f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201278
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2022-09-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189375
Hyphenated Format 72189-375

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/apap (source: ndc)
Generic Name oxycodone/apap (source: ndc)
Application Number ANDA201278 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 7.5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (72189-375-30)
  • 60 TABLET in 1 BOTTLE (72189-375-60)
  • 120 TABLET in 1 BOTTLE (72189-375-72)
  • 90 TABLET in 1 BOTTLE (72189-375-90)
source: ndc

Packages (4)

72189-375-30 30 TABLET in 1 BOTTLE (72189-375-30) 72189-375-60 60 TABLET in 1 BOTTLE (72189-375-60) 72189-375-72 120 TABLET in 1 BOTTLE (72189-375-72) 72189-375-90 90 TABLET in 1 BOTTLE (72189-375-90)

Ingredients (2)

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

Linked Drug Pages (1)

Oxycodone/APAP ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4c4c55ca-eef7-8b39-e063-6294a90adf3f", "openfda": {"unii": ["362O9ITL9D", "C1ENJ2TE6C"], "rxcui": ["1049225"], "spl_set_id": ["e84245ca-957f-e85b-e053-2a95a90a836b"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-375-30)", "package_ndc": "72189-375-30", "marketing_start_date": "20220909"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (72189-375-60)", "package_ndc": "72189-375-60", "marketing_start_date": "20220909"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (72189-375-72)", "package_ndc": "72189-375-72", "marketing_start_date": "20220909"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (72189-375-90)", "package_ndc": "72189-375-90", "marketing_start_date": "20220909"}], "brand_name": "Oxycodone/APAP", "product_id": "72189-375_4c4c55ca-eef7-8b39-e063-6294a90adf3f", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "72189-375", "dea_schedule": "CII", "generic_name": "Oxycodone/APAP", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxycodone/APAP", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "OXYCODONE HYDROCHLORIDE", "strength": "7.5 mg/1"}], "application_number": "ANDA201278", "marketing_category": "ANDA", "marketing_start_date": "20220909", "listing_expiration_date": "20271231"}