oxycodone and acetaminophen

Generic: oxycodone and acetaminophen tablets

Labeler: fh2 pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxycodone and acetaminophen
Generic Name oxycodone and acetaminophen tablets
Labeler fh2 pharma llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 300 mg/1, oxycodone hydrochloride 10 mg/1

Manufacturer
FH2 Pharma LLC

Identifiers & Regulatory

Product NDC 72887-683
Product ID 72887-683_29293789-d966-1f97-e063-6394a90abe03
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040608
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2020-07-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72887683
Hyphenated Format 72887-683

Supplemental Identifiers

RxCUI
1014599 1014615 1014632 1037259
UPC
0372887193039 0372887682038 0372887683035 0372887681031
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 and acetaminophen (source: ndc)
Generic Name oxycodone and acetaminophen tablets (source: ndc)
Application Number ANDA040608 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (72887-683-03)
source: ndc

Packages (1)

72887-683-03 30 TABLET in 1 BOTTLE, PLASTIC (72887-683-03)

Ingredients (2)

acetaminophen (300 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": "29293789-d966-1f97-e063-6394a90abe03", "openfda": {"upc": ["0372887193039", "0372887682038", "0372887683035", "0372887681031"], "unii": ["C1ENJ2TE6C", "362O9ITL9D"], "rxcui": ["1014599", "1014615", "1014632", "1037259"], "spl_set_id": ["88d97caf-bcf5-3cde-e053-2995a90acf4a"], "manufacturer_name": ["FH2 Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (72887-683-03)", "package_ndc": "72887-683-03", "marketing_start_date": "20200925"}], "brand_name": "oxycodone and acetaminophen", "product_id": "72887-683_29293789-d966-1f97-e063-6394a90abe03", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "72887-683", "dea_schedule": "CII", "generic_name": "oxycodone and acetaminophen tablets", "labeler_name": "FH2 Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "oxycodone and acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "300 mg/1"}, {"name": "OXYCODONE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA040608", "marketing_category": "ANDA", "marketing_start_date": "20200701", "listing_expiration_date": "20261231"}