oxycodone hydrochloride

Generic: oxycodone hydrochloride

Labeler: specgx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxycodone hydrochloride
Generic Name oxycodone hydrochloride
Labeler specgx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

oxycodone hydrochloride 20 mg/1

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-8520
Product ID 0406-8520_48d2db7c-2e64-4425-86a5-3ad5289fb7b7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076758
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2021-10-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04068520
Hyphenated Format 0406-8520

Supplemental Identifiers

UPC
0304068515019 0304068520013 0304068510014 0304068530012 0304060552012
UNII
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 oxycodone hydrochloride (source: ndc)
Generic Name oxycodone hydrochloride (source: ndc)
Application Number ANDA076758 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0406-8520-01)
  • 1 TABLET in 1 BLISTER PACK (0406-8520-23)
  • 100 TABLET in 1 BLISTER PACK (0406-8520-62)
source: ndc

Packages (3)

0406-8520-01 100 TABLET in 1 BOTTLE (0406-8520-01) 0406-8520-23 1 TABLET in 1 BLISTER PACK (0406-8520-23) 0406-8520-62 100 TABLET in 1 BLISTER PACK (0406-8520-62)

Ingredients (1)

oxycodone hydrochloride (20 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": "48d2db7c-2e64-4425-86a5-3ad5289fb7b7", "openfda": {"upc": ["0304068515019", "0304068520013", "0304068510014", "0304068530012", "0304060552012"], "unii": ["C1ENJ2TE6C"], "spl_set_id": ["928227bf-89c5-4c64-9823-0e84cc669388"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0406-8520-01)", "package_ndc": "0406-8520-01", "marketing_start_date": "20211012"}, {"sample": false, "description": "1 TABLET in 1 BLISTER PACK (0406-8520-23)", "package_ndc": "0406-8520-23", "marketing_start_date": "20211012"}, {"sample": false, "description": "100 TABLET in 1 BLISTER PACK (0406-8520-62)", "package_ndc": "0406-8520-62", "marketing_start_date": "20211012"}], "brand_name": "OXYCODONE HYDROCHLORIDE", "product_id": "0406-8520_48d2db7c-2e64-4425-86a5-3ad5289fb7b7", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0406-8520", "dea_schedule": "CII", "generic_name": "oxycodone hydrochloride", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OXYCODONE HYDROCHLORIDE", "active_ingredients": [{"name": "OXYCODONE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA076758", "marketing_category": "ANDA", "marketing_start_date": "20211012", "listing_expiration_date": "20261231"}