oxycodone hydrochloride oral solution (13107-261)

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 5 mg/5mL

Manufacturer

Aurolife Pharma, LLC

Identifiers & Regulatory

Product NDC 13107-261

Product ID 13107-261_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 13107261

Hyphenated Format 13107-261

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

5 mg/5mL

source: ndc

Packaging

1 BOTTLE in 1 CARTON (13107-261-58) / 500 mL in 1 BOTTLE

source: ndc

Packages (1)

13107-261-58 1 BOTTLE in 1 CARTON (13107-261-58) / 500 mL in 1 BOTTLE

Ingredients (1)

oxycodone hydrochloride (5 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 (13107-261-58)  / 500 mL in 1 BOTTLE", "package_ndc": "13107-261-58", "marketing_start_date": "20200127"}], "brand_name": "Oxycodone Hydrochloride Oral Solution", "product_id": "13107-261_b0905edb-577e-4e2e-ab2f-c7f5c673b0e1", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "13107-261", "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": "5 mg/5mL"}], "application_number": "ANDA212429", "marketing_category": "ANDA", "marketing_start_date": "20200127", "listing_expiration_date": "20261231"}