oxycodone hydrochloride and acetaminophen

Generic: oxycodone hydrochloride and acetaminophen

Labeler: elite laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxycodone hydrochloride and acetaminophen
Generic Name oxycodone hydrochloride and acetaminophen
Labeler elite laboratories, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Elite Laboratories, Inc.

Identifiers & Regulatory

Product NDC 64850-623
Product ID 64850-623_6371920d-34a5-41ac-ba08-3b91fd68075b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209385
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2017-12-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64850623
Hyphenated Format 64850-623

Supplemental Identifiers

RxCUI
1049214 1049221 1049225
UPC
0364850621014 0364850622011 0364850623018
UNII
C1ENJ2TE6C 362O9ITL9D

Packaging Origin

Original Packager
true

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 hydrochloride and acetaminophen (source: ndc)
Generic Name oxycodone hydrochloride and acetaminophen (source: ndc)
Application Number ANDA209385 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (64850-623-01)
source: ndc

Packages (1)

64850-623-01 100 TABLET in 1 BOTTLE (64850-623-01)

Ingredients (2)

acetaminophen (325 mg/1) oxycodone hydrochloride (10 mg/1)

Linked Drug Pages (1)

Oxycodone Hydrochloride and Acetaminophen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6371920d-34a5-41ac-ba08-3b91fd68075b", "openfda": {"upc": ["0364850621014", "0364850622011", "0364850623018"], "unii": ["C1ENJ2TE6C", "362O9ITL9D"], "rxcui": ["1049214", "1049221", "1049225"], "spl_set_id": ["27fa8190-d334-4bb9-b277-d1f44db433e3"], "manufacturer_name": ["Elite Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (64850-623-01)", "package_ndc": "64850-623-01", "marketing_start_date": "20171204"}], "brand_name": "Oxycodone Hydrochloride and Acetaminophen", "product_id": "64850-623_6371920d-34a5-41ac-ba08-3b91fd68075b", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "64850-623", "dea_schedule": "CII", "generic_name": "Oxycodone Hydrochloride and Acetaminophen", "labeler_name": "Elite Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxycodone Hydrochloride and Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "OXYCODONE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA209385", "marketing_category": "ANDA", "marketing_start_date": "20171204", "listing_expiration_date": "20261231"}