oxycodone and acetaminophen (10702-187)

Drug Facts

Product Profile

Brand Name oxycodone and acetaminophen

Generic Name oxycodone and acetaminophen

Labeler kvk-tech, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

acetaminophen 325 mg/1, oxycodone 10 mg/1

Manufacturer

KVK-Tech, Inc.

Identifiers & Regulatory

Product NDC 10702-187

Product ID 10702-187_49d88f78-4902-4a91-e063-6294a90a1626

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA210644

DEA Schedule cii

Listing Expiration 2027-12-31

Marketing Start 2018-02-09

Pharmacologic Class

Established (EPC)

opioid agonist [epc]

Mechanism of Action

full opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10702187

Hyphenated Format 10702-187

Supplemental Identifiers

RxCUI

1049214 1049221 1049225 1049635

UPC

0310702185500 0310702184107 0310702187108 0310702185104 0310702186101 0310702186507

UNII

362O9ITL9D CD35PMG570

NUI

N0000175684 N0000175690

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 ANDA210644 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/1
10 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (10702-187-01)
1000 TABLET in 1 BOTTLE (10702-187-10)
500 TABLET in 1 BOTTLE (10702-187-50)

source: ndc

Packages (3)

10702-187-01 100 TABLET in 1 BOTTLE (10702-187-01) 10702-187-10 1000 TABLET in 1 BOTTLE (10702-187-10) 10702-187-50 500 TABLET in 1 BOTTLE (10702-187-50)

Ingredients (2)

acetaminophen (325 mg/1) oxycodone (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": "49d88f78-4902-4a91-e063-6294a90a1626", "openfda": {"nui": ["N0000175684", "N0000175690"], "upc": ["0310702185500", "0310702184107", "0310702187108", "0310702185104", "0310702186101", "0310702186507"], "unii": ["362O9ITL9D", "CD35PMG570"], "rxcui": ["1049214", "1049221", "1049225", "1049635"], "spl_set_id": ["f9cf218c-af5e-4249-aa3b-a8555ed02278"], "pharm_class_epc": ["Opioid Agonist [EPC]"], "pharm_class_moa": ["Full Opioid Agonists [MoA]"], "manufacturer_name": ["KVK-Tech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (10702-187-01)", "package_ndc": "10702-187-01", "marketing_start_date": "20180209"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (10702-187-10)", "package_ndc": "10702-187-10", "marketing_start_date": "20180209"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (10702-187-50)", "package_ndc": "10702-187-50", "marketing_start_date": "20180209"}], "brand_name": "Oxycodone and Acetaminophen", "product_id": "10702-187_49d88f78-4902-4a91-e063-6294a90a1626", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "10702-187", "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/1"}, {"name": "OXYCODONE", "strength": "10 mg/1"}], "application_number": "ANDA210644", "marketing_category": "ANDA", "marketing_start_date": "20180209", "listing_expiration_date": "20271231"}