oxycodone and acetaminophen

Generic: oxycodone and acetaminophen

Labeler: kvk-tech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxycodone and acetaminophen
Generic Name oxycodone and acetaminophen
Labeler kvk-tech, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/5mL, oxycodone hydrochloride 5 mg/5mL

Manufacturer
KVK-Tech, Inc.

Identifiers & Regulatory

Product NDC 10702-238
Product ID 10702-238_483734fe-f7da-e43c-e063-6294a90a8191
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211499
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2019-12-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10702238
Hyphenated Format 10702-238

Supplemental Identifiers

RxCUI
1049580
UNII
362O9ITL9D C1ENJ2TE6C

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 and acetaminophen (source: ndc)
Generic Name oxycodone and acetaminophen (source: ndc)
Application Number ANDA211499 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/5mL
  • 5 mg/5mL
source: ndc
Packaging
  • 500 mL in 1 BOTTLE (10702-238-50)
source: ndc

Packages (1)

10702-238-50 500 mL in 1 BOTTLE (10702-238-50)

Ingredients (2)

acetaminophen (325 mg/5mL) oxycodone hydrochloride (5 mg/5mL)

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": "483734fe-f7da-e43c-e063-6294a90a8191", "openfda": {"unii": ["362O9ITL9D", "C1ENJ2TE6C"], "rxcui": ["1049580"], "spl_set_id": ["9986aa04-c976-4654-8ad7-b97d2eecea93"], "manufacturer_name": ["KVK-Tech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 mL in 1 BOTTLE (10702-238-50)", "package_ndc": "10702-238-50", "marketing_start_date": "20191205"}], "brand_name": "OXYCODONE AND ACETAMINOPHEN", "product_id": "10702-238_483734fe-f7da-e43c-e063-6294a90a8191", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "10702-238", "dea_schedule": "CII", "generic_name": "oxycodone and acetaminophen", "labeler_name": "KVK-Tech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OXYCODONE AND ACETAMINOPHEN", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/5mL"}, {"name": "OXYCODONE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "ANDA211499", "marketing_category": "ANDA", "marketing_start_date": "20191205", "listing_expiration_date": "20271231"}