endocet

Generic: oxycodone and acetaminophen

Labeler: par health usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name endocet
Generic Name oxycodone and acetaminophen
Labeler par health usa, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, oxycodone hydrochloride 5 mg/1

Manufacturer
Par Health USA, LLC

Identifiers & Regulatory

Product NDC 60951-602
Product ID 60951-602_097fa5e7-7122-439a-8ac9-c85766003509
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040330
DEA Schedule cii
Marketing Start 2000-05-26
Marketing End 2027-03-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60951602
Hyphenated Format 60951-602

Supplemental Identifiers

RxCUI
1049214 1049216 1049221 1049223 1049225 1049227 1049635 1487288
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 endocet (source: ndc)
Generic Name oxycodone and acetaminophen (source: ndc)
Application Number ANDA040330 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (60951-602-70)
  • 500 TABLET in 1 BOTTLE (60951-602-85)
source: ndc

Packages (2)

60951-602-70 100 TABLET in 1 BOTTLE (60951-602-70) 60951-602-85 500 TABLET in 1 BOTTLE (60951-602-85)

Ingredients (2)

acetaminophen (325 mg/1) oxycodone hydrochloride (5 mg/1)

Linked Drug Pages (1)

ENDOCET ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "097fa5e7-7122-439a-8ac9-c85766003509", "openfda": {"unii": ["C1ENJ2TE6C", "362O9ITL9D"], "rxcui": ["1049214", "1049216", "1049221", "1049223", "1049225", "1049227", "1049635", "1487288"], "spl_set_id": ["944d3e60-7eee-11de-a413-0002a5d5c51b"], "manufacturer_name": ["Par Health USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (60951-602-70)", "package_ndc": "60951-602-70", "marketing_end_date": "20270331", "marketing_start_date": "20000526"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (60951-602-85)", "package_ndc": "60951-602-85", "marketing_end_date": "20261031", "marketing_start_date": "20000526"}], "brand_name": "ENDOCET", "product_id": "60951-602_097fa5e7-7122-439a-8ac9-c85766003509", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "60951-602", "dea_schedule": "CII", "generic_name": "Oxycodone and Acetaminophen", "labeler_name": "Par Health USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ENDOCET", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "OXYCODONE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA040330", "marketing_category": "ANDA", "marketing_end_date": "20270331", "marketing_start_date": "20000526"}