oxycodone hydrochloride

Generic: oxycodone hydrochloride

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

Drug Facts

Product Profile

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

oxycodone hydrochloride 20 mg/1

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-434
Product ID 43386-434_78c8a4dc-d475-41ca-acf7-9078e9c36c7f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204021
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2017-06-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43386434
Hyphenated Format 43386-434

Supplemental Identifiers

RxCUI
1049611 1049618 1049621 1049683 1049686
UPC
0343386434015 0343386434039 0343386430031 0343386432059 0343386431052 0343386430017 0343386433032 0343386433018 0343386431038 0343386432011 0343386432035 0343386431014
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 ANDA204021 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (43386-434-01)
source: ndc

Packages (1)

43386-434-01 100 TABLET in 1 BOTTLE (43386-434-01)

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": "78c8a4dc-d475-41ca-acf7-9078e9c36c7f", "openfda": {"upc": ["0343386434015", "0343386434039", "0343386430031", "0343386432059", "0343386431052", "0343386430017", "0343386433032", "0343386433018", "0343386431038", "0343386432011", "0343386432035", "0343386431014"], "unii": ["C1ENJ2TE6C"], "rxcui": ["1049611", "1049618", "1049621", "1049683", "1049686"], "spl_set_id": ["801cb437-c189-44f5-83eb-a51c365d8a6b"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (43386-434-01)", "package_ndc": "43386-434-01", "marketing_start_date": "20170612"}], "brand_name": "Oxycodone Hydrochloride", "product_id": "43386-434_78c8a4dc-d475-41ca-acf7-9078e9c36c7f", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "43386-434", "dea_schedule": "CII", "generic_name": "Oxycodone Hydrochloride", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxycodone Hydrochloride", "active_ingredients": [{"name": "OXYCODONE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA204021", "marketing_category": "ANDA", "marketing_start_date": "20170612", "listing_expiration_date": "20261231"}