prolate

Generic: oxycodone 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 and acetaminophen
Labeler forte bio-pharma llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 300 mg/1, oxycodone hydrochloride 7.5 mg/1

Manufacturer
Forte Bio-Pharma LLC

Identifiers & Regulatory

Product NDC 72245-682
Product ID 72245-682_4c0a051e-78a7-de5f-e063-6294a90a90c9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040608
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2020-02-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72245682
Hyphenated Format 72245-682

Supplemental Identifiers

RxCUI
1014599 1014615 1014632 2279510 2279512 2279514
UPC
0372245682106 0372245681109 0372245683103
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 prolate (source: ndc)
Generic Name oxycodone and acetaminophen (source: ndc)
Application Number ANDA040608 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
  • 7.5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (72245-682-03)
  • 100 TABLET in 1 BOTTLE, PLASTIC (72245-682-10)
source: ndc

Packages (2)

72245-682-03 30 TABLET in 1 BOTTLE, PLASTIC (72245-682-03) 72245-682-10 100 TABLET in 1 BOTTLE, PLASTIC (72245-682-10)

Ingredients (2)

acetaminophen (300 mg/1) oxycodone hydrochloride (7.5 mg/1)

Linked Drug Pages (1)

Prolate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4c0a051e-78a7-de5f-e063-6294a90a90c9", "openfda": {"upc": ["0372245682106", "0372245681109", "0372245683103"], "unii": ["C1ENJ2TE6C", "362O9ITL9D"], "rxcui": ["1014599", "1014615", "1014632", "2279510", "2279512", "2279514"], "spl_set_id": ["9cbbfa94-37b9-9652-e053-2995a90a736b"], "manufacturer_name": ["Forte Bio-Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (72245-682-03)", "package_ndc": "72245-682-03", "marketing_start_date": "20200217"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (72245-682-10)", "package_ndc": "72245-682-10", "marketing_start_date": "20200217"}], "brand_name": "Prolate", "product_id": "72245-682_4c0a051e-78a7-de5f-e063-6294a90a90c9", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "72245-682", "dea_schedule": "CII", "generic_name": "oxycodone and acetaminophen", "labeler_name": "Forte Bio-Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prolate", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "300 mg/1"}, {"name": "OXYCODONE HYDROCHLORIDE", "strength": "7.5 mg/1"}], "application_number": "ANDA040608", "marketing_category": "ANDA", "marketing_start_date": "20200217", "listing_expiration_date": "20271231"}