oxycodone hydrochloride and acetaminophen

Generic: oxycodone hydrochloride and acetaminophen

Labeler: fh2 pharma llc
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 fh2 pharma llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 300 mg/5mL, oxycodone hydrochloride 10 mg/5mL

Manufacturer
FH2 Pharma LLC

Identifiers & Regulatory

Product NDC 72887-648
Product ID 72887-648_42f2bb2a-1520-86cb-e063-6394a90a3a00
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202142
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2020-03-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72887648
Hyphenated Format 72887-648

Supplemental Identifiers

RxCUI
2105822
UPC
0372887648126
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 hydrochloride and acetaminophen (source: ndc)
Generic Name oxycodone hydrochloride and acetaminophen (source: ndc)
Application Number ANDA202142 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/5mL
  • 10 mg/5mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE, PLASTIC (72887-648-12)
source: ndc

Packages (1)

72887-648-12 120 mL in 1 BOTTLE, PLASTIC (72887-648-12)

Ingredients (2)

acetaminophen (300 mg/5mL) oxycodone hydrochloride (10 mg/5mL)

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": "42f2bb2a-1520-86cb-e063-6394a90a3a00", "openfda": {"upc": ["0372887648126"], "unii": ["362O9ITL9D", "C1ENJ2TE6C"], "rxcui": ["2105822"], "spl_set_id": ["96b0067e-aabe-df4f-e053-2995a90a4a86"], "manufacturer_name": ["FH2 Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE, PLASTIC (72887-648-12)", "package_ndc": "72887-648-12", "marketing_start_date": "20200301"}], "brand_name": "oxycodone hydrochloride and acetaminophen", "product_id": "72887-648_42f2bb2a-1520-86cb-e063-6394a90a3a00", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "72887-648", "dea_schedule": "CII", "generic_name": "oxycodone hydrochloride and acetaminophen", "labeler_name": "FH2 Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "oxycodone hydrochloride and acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "300 mg/5mL"}, {"name": "OXYCODONE HYDROCHLORIDE", "strength": "10 mg/5mL"}], "application_number": "ANDA202142", "marketing_category": "ANDA", "marketing_start_date": "20200301", "listing_expiration_date": "20261231"}