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 10 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 61919-871
Product ID 61919-871_3a85db26-4c30-c5dc-e063-6294a90ac2a2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207419
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2019-08-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61919871
Hyphenated Format 61919-871

Supplemental Identifiers

RxCUI
1049214
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
  • 10 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (61919-871-60)
  • 120 TABLET in 1 BOTTLE (61919-871-72)
source: ndc

Packages (2)

61919-871-60 60 TABLET in 1 BOTTLE (61919-871-60) 61919-871-72 120 TABLET in 1 BOTTLE (61919-871-72)

Ingredients (2)

acetaminophen (325 mg/1) oxycodone hydrochloride (10 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": "3a85db26-4c30-c5dc-e063-6294a90ac2a2", "openfda": {"unii": ["362O9ITL9D", "C1ENJ2TE6C"], "rxcui": ["1049214"], "spl_set_id": ["90a11364-fc42-e94e-e053-2a95a90a9782"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (61919-871-60)", "package_ndc": "61919-871-60", "marketing_start_date": "20190821"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (61919-871-72)", "package_ndc": "61919-871-72", "marketing_start_date": "20190821"}], "brand_name": "OXYCODONE AND ACETAMINOPHEN", "product_id": "61919-871_3a85db26-4c30-c5dc-e063-6294a90ac2a2", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "61919-871", "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": "10 mg/1"}], "application_number": "ANDA207419", "marketing_category": "ANDA", "marketing_start_date": "20190821", "listing_expiration_date": "20261231"}