oxycodone and acetaminophen

Generic: oxycodone and acetaminophen

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxycodone and acetaminophen
Generic Name oxycodone and acetaminophen
Labeler asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, oxycodone hydrochloride 10 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-209
Product ID 76420-209_de3d43dc-ba4c-e233-e053-2995a90ac632
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201278
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2014-08-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420209
Hyphenated Format 76420-209

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 ANDA201278 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (76420-209-01)
  • 30 TABLET in 1 BOTTLE, PLASTIC (76420-209-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (76420-209-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (76420-209-90)
source: ndc

Packages (4)

76420-209-01 100 TABLET in 1 BOTTLE, PLASTIC (76420-209-01) 76420-209-30 30 TABLET in 1 BOTTLE, PLASTIC (76420-209-30) 76420-209-60 60 TABLET in 1 BOTTLE, PLASTIC (76420-209-60) 76420-209-90 90 TABLET in 1 BOTTLE, PLASTIC (76420-209-90)

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": "de3d43dc-ba4c-e233-e053-2995a90ac632", "openfda": {"unii": ["362O9ITL9D", "C1ENJ2TE6C"], "rxcui": ["1049214"], "spl_set_id": ["3e89f02d-b6e7-4641-82d4-f756518a8914"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (76420-209-01)", "package_ndc": "76420-209-01", "marketing_start_date": "20220505"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (76420-209-30)", "package_ndc": "76420-209-30", "marketing_start_date": "20220505"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (76420-209-60)", "package_ndc": "76420-209-60", "marketing_start_date": "20220505"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (76420-209-90)", "package_ndc": "76420-209-90", "marketing_start_date": "20220505"}], "brand_name": "Oxycodone and Acetaminophen", "product_id": "76420-209_de3d43dc-ba4c-e233-e053-2995a90ac632", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "76420-209", "dea_schedule": "CII", "generic_name": "Oxycodone and Acetaminophen", "labeler_name": "Asclemed USA, Inc.", "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": "ANDA201278", "marketing_category": "ANDA", "marketing_start_date": "20140828", "listing_expiration_date": "20261231"}