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 5 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-321
Product ID 76420-321_32cd8c6c-83cf-fa16-e063-6394a90a6f38
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207419
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2017-04-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420321
Hyphenated Format 76420-321

Supplemental Identifiers

RxCUI
1049214 1049221 1049225 1049635
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 ANDA207419 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (76420-321-01)
  • 500 TABLET in 1 BOTTLE (76420-321-05)
  • 30 TABLET in 1 BOTTLE (76420-321-30)
  • 60 TABLET in 1 BOTTLE (76420-321-60)
  • 90 TABLET in 1 BOTTLE (76420-321-90)
source: ndc

Packages (5)

76420-321-01 100 TABLET in 1 BOTTLE (76420-321-01) 76420-321-05 500 TABLET in 1 BOTTLE (76420-321-05) 76420-321-30 30 TABLET in 1 BOTTLE (76420-321-30) 76420-321-60 60 TABLET in 1 BOTTLE (76420-321-60) 76420-321-90 90 TABLET in 1 BOTTLE (76420-321-90)

Ingredients (2)

acetaminophen (325 mg/1) oxycodone hydrochloride (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": "32cd8c6c-83cf-fa16-e063-6394a90a6f38", "openfda": {"unii": ["C1ENJ2TE6C", "362O9ITL9D"], "rxcui": ["1049214", "1049221", "1049225", "1049635"], "spl_set_id": ["71c7a627-6ed9-4f49-8cdc-b3228c021e64"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76420-321-01)", "package_ndc": "76420-321-01", "marketing_start_date": "20250415"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (76420-321-05)", "package_ndc": "76420-321-05", "marketing_start_date": "20250415"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (76420-321-30)", "package_ndc": "76420-321-30", "marketing_start_date": "20250415"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (76420-321-60)", "package_ndc": "76420-321-60", "marketing_start_date": "20250415"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (76420-321-90)", "package_ndc": "76420-321-90", "marketing_start_date": "20250415"}], "brand_name": "OXYCODONE AND ACETAMINOPHEN", "product_id": "76420-321_32cd8c6c-83cf-fa16-e063-6394a90a6f38", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "76420-321", "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": "5 mg/1"}], "application_number": "ANDA207419", "marketing_category": "ANDA", "marketing_start_date": "20170411", "listing_expiration_date": "20261231"}