oxycodone hydrochloride

Generic: oxycodone hydrochloride

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

Drug Facts

Product Profile

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

oxycodone hydrochloride 15 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-975
Product ID 68084-975_4160b55c-48e1-5cb4-e063-6294a90a1d7d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091393
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2020-02-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68084975
Hyphenated Format 68084-975

Supplemental Identifiers

RxCUI
1049611 1049618 1049621 1049683
UNII
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 hydrochloride (source: ndc)
Generic Name oxycodone hydrochloride (source: ndc)
Application Number ANDA091393 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (68084-975-01) / 1 TABLET in 1 BLISTER PACK (68084-975-11)
source: ndc

Packages (1)

68084-975-01 100 BLISTER PACK in 1 CARTON (68084-975-01) / 1 TABLET in 1 BLISTER PACK (68084-975-11)

Ingredients (1)

oxycodone hydrochloride (15 mg/1)

Linked Drug Pages (1)

OXYCODONE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4160b55c-48e1-5cb4-e063-6294a90a1d7d", "openfda": {"unii": ["C1ENJ2TE6C"], "rxcui": ["1049611", "1049618", "1049621", "1049683"], "spl_set_id": ["aa7ac2bf-d9ed-445d-b394-4d3fe39780ca"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (68084-975-01)  / 1 TABLET in 1 BLISTER PACK (68084-975-11)", "package_ndc": "68084-975-01", "marketing_start_date": "20200225"}], "brand_name": "OXYCODONE HYDROCHLORIDE", "product_id": "68084-975_4160b55c-48e1-5cb4-e063-6294a90a1d7d", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "68084-975", "dea_schedule": "CII", "generic_name": "OXYCODONE HYDROCHLORIDE", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OXYCODONE HYDROCHLORIDE", "active_ingredients": [{"name": "OXYCODONE HYDROCHLORIDE", "strength": "15 mg/1"}], "application_number": "ANDA091393", "marketing_category": "ANDA", "marketing_start_date": "20200225", "listing_expiration_date": "20261231"}