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 SOLUTION
Routes
ORAL
Active Ingredients

oxycodone hydrochloride 100 mg/5mL

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-8557
Product ID 0406-8557_7e788fe5-6049-4ff6-a09a-60e8b9e52d9d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210758
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2018-04-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04068557
Hyphenated Format 0406-8557

Supplemental Identifiers

RxCUI
1049604 1049615
UPC
0304068556050 0304068557309
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 ANDA210758 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (0406-8557-30) / 30 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

0406-8557-30 1 BOTTLE, PLASTIC in 1 CARTON (0406-8557-30) / 30 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

oxycodone hydrochloride (100 mg/5mL)

Linked Drug Pages (1)

Oxycodone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7e788fe5-6049-4ff6-a09a-60e8b9e52d9d", "openfda": {"upc": ["0304068556050", "0304068557309"], "unii": ["C1ENJ2TE6C"], "rxcui": ["1049604", "1049615"], "spl_set_id": ["5451bcaa-0aca-4581-bcea-2f9c2a33b260"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0406-8557-30)  / 30 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0406-8557-30", "marketing_start_date": "20180430"}], "brand_name": "Oxycodone Hydrochloride", "product_id": "0406-8557_7e788fe5-6049-4ff6-a09a-60e8b9e52d9d", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0406-8557", "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": "100 mg/5mL"}], "application_number": "ANDA210758", "marketing_category": "ANDA", "marketing_start_date": "20180430", "listing_expiration_date": "20261231"}