oxycodone hydrochloride

Generic: oxycodone hydrochloride

Labeler: alvogen, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxycodone hydrochloride
Generic Name oxycodone hydrochloride
Labeler alvogen, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

oxycodone hydrochloride 15 mg/1

Manufacturer
Alvogen, Inc.

Identifiers & Regulatory

Product NDC 47781-264
Product ID 47781-264_aa023689-6275-e0a0-ab08-d45edc45ec40
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202116
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2011-12-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47781264
Hyphenated Format 47781-264

Supplemental Identifiers

RxCUI
1049611 1049618 1049621
UPC
0347781264017 0347781263010 0347781265014
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 ANDA202116 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (47781-264-01)
  • 500 TABLET in 1 BOTTLE (47781-264-05)
source: ndc

Packages (2)

47781-264-01 100 TABLET in 1 BOTTLE (47781-264-01) 47781-264-05 500 TABLET in 1 BOTTLE (47781-264-05)

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": "aa023689-6275-e0a0-ab08-d45edc45ec40", "openfda": {"upc": ["0347781264017", "0347781263010", "0347781265014"], "unii": ["C1ENJ2TE6C"], "rxcui": ["1049611", "1049618", "1049621"], "spl_set_id": ["20bb6bb4-230a-c9c2-01d8-a6e9341e96ba"], "manufacturer_name": ["Alvogen, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (47781-264-01)", "package_ndc": "47781-264-01", "marketing_start_date": "20111230"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (47781-264-05)", "package_ndc": "47781-264-05", "marketing_start_date": "20111230"}], "brand_name": "Oxycodone hydrochloride", "product_id": "47781-264_aa023689-6275-e0a0-ab08-d45edc45ec40", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "47781-264", "dea_schedule": "CII", "generic_name": "Oxycodone hydrochloride", "labeler_name": "Alvogen, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxycodone hydrochloride", "active_ingredients": [{"name": "OXYCODONE HYDROCHLORIDE", "strength": "15 mg/1"}], "application_number": "ANDA202116", "marketing_category": "ANDA", "marketing_start_date": "20111230", "listing_expiration_date": "20271231"}