oxycodone and acetaminophen

Generic: oxycodone and acetaminophen

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxycodone and acetaminophen
Generic Name oxycodone and acetaminophen
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-642
Product ID 60687-642_446cc62f-293a-f35e-e063-6294a90a7dd0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207510
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2022-01-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687642
Hyphenated Format 60687-642

Supplemental Identifiers

RxCUI
1049221
UNII
362O9ITL9D C1ENJ2TE6C

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 (source: ndc)
Application Number ANDA207510 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (60687-642-01) / 1 TABLET in 1 BLISTER PACK (60687-642-11)
source: ndc

Packages (1)

60687-642-01 100 BLISTER PACK in 1 CARTON (60687-642-01) / 1 TABLET in 1 BLISTER PACK (60687-642-11)

Ingredients (2)

acetaminophen (325 mg/1) oxycodone hydrochloride (5 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": "446cc62f-293a-f35e-e063-6294a90a7dd0", "openfda": {"unii": ["362O9ITL9D", "C1ENJ2TE6C"], "rxcui": ["1049221"], "spl_set_id": ["79bb61d7-8836-4ce7-91bc-9463efbad9cf"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (60687-642-01)  / 1 TABLET in 1 BLISTER PACK (60687-642-11)", "package_ndc": "60687-642-01", "marketing_start_date": "20220104"}], "brand_name": "Oxycodone and Acetaminophen", "product_id": "60687-642_446cc62f-293a-f35e-e063-6294a90a7dd0", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "60687-642", "dea_schedule": "CII", "generic_name": "Oxycodone and Acetaminophen", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxycodone and Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "OXYCODONE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA207510", "marketing_category": "ANDA", "marketing_start_date": "20220104", "listing_expiration_date": "20261231"}