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 SOLUTION
Routes
ORAL
Active Ingredients

oxycodone hydrochloride 20 mg/mL

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43386-920
Product ID 43386-920_e5a8251c-8fc6-4b34-a01f-1706ebda9f94
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204603
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2015-04-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43386920
Hyphenated Format 43386-920

Supplemental Identifiers

RxCUI
1049615
UPC
0343386920600
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 ANDA204603 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (43386-920-60) / 30 mL in 1 BOTTLE
source: ndc

Packages (1)

43386-920-60 1 BOTTLE in 1 CARTON (43386-920-60) / 30 mL in 1 BOTTLE

Ingredients (1)

oxycodone hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Oxycodone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e5a8251c-8fc6-4b34-a01f-1706ebda9f94", "openfda": {"upc": ["0343386920600"], "unii": ["C1ENJ2TE6C"], "rxcui": ["1049615"], "spl_set_id": ["3eddd18b-695a-4e53-a76c-f6779515b918"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (43386-920-60)  / 30 mL in 1 BOTTLE", "package_ndc": "43386-920-60", "marketing_start_date": "20150429"}], "brand_name": "Oxycodone Hydrochloride", "product_id": "43386-920_e5a8251c-8fc6-4b34-a01f-1706ebda9f94", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "43386-920", "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/mL"}], "application_number": "ANDA204603", "marketing_category": "ANDA", "marketing_start_date": "20150429", "listing_expiration_date": "20261231"}