prolate

Generic: oxycodone hydrochloride and acetaminophen

Labeler: forte bio-pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prolate
Generic Name oxycodone hydrochloride and acetaminophen
Labeler forte bio-pharma llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
Forte Bio-Pharma LLC

Identifiers & Regulatory

Product NDC 72245-648
Product ID 72245-648_438ed581-51ff-3746-e063-6294a90a830c
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 72245648
Hyphenated Format 72245-648

Supplemental Identifiers

RxCUI
2105822 2281851
UPC
0372245648126
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 prolate (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 (72245-648-12)
  • 500 mL in 1 BOTTLE, PLASTIC (72245-648-50)
source: ndc

Packages (2)

72245-648-12 120 mL in 1 BOTTLE, PLASTIC (72245-648-12) 72245-648-50 500 mL in 1 BOTTLE, PLASTIC (72245-648-50)

Ingredients (2)

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

Linked Drug Pages (1)

Prolate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "438ed581-51ff-3746-e063-6294a90a830c", "openfda": {"upc": ["0372245648126"], "unii": ["362O9ITL9D", "C1ENJ2TE6C"], "rxcui": ["2105822", "2281851"], "spl_set_id": ["9d75ad3b-bc9b-0c22-e053-2a95a90ac71e"], "manufacturer_name": ["Forte Bio-Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE, PLASTIC (72245-648-12)", "package_ndc": "72245-648-12", "marketing_start_date": "20200301"}, {"sample": false, "description": "500 mL in 1 BOTTLE, PLASTIC (72245-648-50)", "package_ndc": "72245-648-50", "marketing_start_date": "20200301"}], "brand_name": "Prolate", "product_id": "72245-648_438ed581-51ff-3746-e063-6294a90a830c", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "72245-648", "dea_schedule": "CII", "generic_name": "oxycodone hydrochloride and acetaminophen", "labeler_name": "Forte Bio-Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prolate", "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"}