NDC 13107-261

Oxycodone Hydrochloride Oral Solution

Oxycodone Hydrochloride Oral Solution

Oxycodone Hydrochloride Oral Solution is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Aurolife Pharma, Llc. The primary component is Oxycodone Hydrochloride.

• Product ID: 13107-261_0b3fa92e-8351-4401-860d-4bba8a7155e6
• NDC: 13107-261
• Product Type: Human Prescription Drug
• Proprietary Name: Oxycodone Hydrochloride Oral Solution
• Generic Name: Oxycodone Hydrochloride Oral Solution
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2020-01-27
• Marketing Category: ANDA / ANDA
• Application Number: ANDA212429
• Labeler Name: Aurolife Pharma, LLC
• Substance Name: OXYCODONE HYDROCHLORIDE
• Active Ingredient Strength: 5 mg/5mL
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 13107-261-58

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

• Marketing Start Date: 2020-01-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 13107-261-58 [13107026158]

Oxycodone Hydrochloride Oral Solution SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA212429
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-01-27

Drug Details

Active Ingredients

Ingredient	Strength
OXYCODONE HYDROCHLORIDE	5 mg/5mL

Pharmacological Class

• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]

NDC Crossover Matching brand name "Oxycodone Hydrochloride Oral Solution" or generic name "Oxycodone Hydrochloride Oral Solution"

NDC	Brand Name	Generic Name
13107-261	Oxycodone Hydrochloride Oral Solution	Oxycodone Hydrochloride Oral Solution
13107-262	Oxycodone Hydrochloride Oral Solution	Oxycodone Hydrochloride Oral Solution