oxycodone hydrochloride oral solution (13107-262)

Drug Facts

Product Profile

Brand Name oxycodone hydrochloride oral solution

Generic Name oxycodone hydrochloride oral solution

Labeler aurolife pharma, llc

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

oxycodone hydrochloride 100 mg/5mL

Manufacturer

Aurolife Pharma, LLC

Identifiers & Regulatory

Product NDC 13107-262

Product ID 13107-262_b0905edb-577e-4e2e-ab2f-c7f5c673b0e1

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA212429

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2020-01-27

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13107262

Hyphenated Format 13107-262

Supplemental Identifiers

RxCUI

1049604 1049615

UPC

0313107262579 0313107261589

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 oral solution (source: ndc)

Generic Name oxycodone hydrochloride oral solution (source: ndc)

Application Number ANDA212429 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

100 mg/5mL

source: ndc

Packaging

1 BOTTLE in 1 CARTON (13107-262-57) / 30 mL in 1 BOTTLE

source: ndc

Packages (1)

13107-262-57 1 BOTTLE in 1 CARTON (13107-262-57) / 30 mL in 1 BOTTLE

Ingredients (1)

oxycodone hydrochloride (100 mg/5mL)

Linked Drug Pages (1)

Oxycodone Hydrochloride Oral Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "b0905edb-577e-4e2e-ab2f-c7f5c673b0e1", "openfda": {"upc": ["0313107262579", "0313107261589"], "unii": ["C1ENJ2TE6C"], "rxcui": ["1049604", "1049615"], "spl_set_id": ["0b3fa92e-8351-4401-860d-4bba8a7155e6"], "manufacturer_name": ["Aurolife Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (13107-262-57)  / 30 mL in 1 BOTTLE", "package_ndc": "13107-262-57", "marketing_start_date": "20200127"}], "brand_name": "Oxycodone Hydrochloride Oral Solution", "product_id": "13107-262_b0905edb-577e-4e2e-ab2f-c7f5c673b0e1", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "13107-262", "dea_schedule": "CII", "generic_name": "Oxycodone Hydrochloride Oral Solution", "labeler_name": "Aurolife Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxycodone Hydrochloride Oral Solution", "active_ingredients": [{"name": "OXYCODONE HYDROCHLORIDE", "strength": "100 mg/5mL"}], "application_number": "ANDA212429", "marketing_category": "ANDA", "marketing_start_date": "20200127", "listing_expiration_date": "20261231"}