NDC 65597-501

Roxybond

Oxycodone Hydrochloride

Roxybond is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Daiichi Sankyo Inc.. The primary component is Oxycodone Hydrochloride.

• Product ID: 65597-501_0f4eb1c1-d334-499a-9be7-6a2fa9f7cdf9
• NDC: 65597-501
• Product Type: Human Prescription Drug
• Proprietary Name: Roxybond
• Generic Name: Oxycodone Hydrochloride
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-04-20
• Marketing Category: NDA / NDA
• Application Number: NDA209777
• Labeler Name: Daiichi Sankyo Inc.
• Substance Name: OXYCODONE HYDROCHLORIDE
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 65597-501-10

100 TABLET, COATED in 1 BOTTLE, PLASTIC (65597-501-10)

• Marketing Start Date: 2018-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65597-501-10 [65597050110]

Roxybond TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA209777
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-04-20
• Marketing End Date: 2017-04-21

Drug Details

Active Ingredients

Ingredient	Strength
OXYCODONE HYDROCHLORIDE	5 mg/1

OpenFDA Data

• SPL SET ID: 2d0eca5d-fe5f-410b-991e-5e365c173703
• Manufacturer:
  • Daiichi Sankyo Inc.
• UNII:
  • C1ENJ2TE6C
• RxNorm Concept Unique ID - RxCUI:
  • 1944535
  • 1944529
  • 1944540
  • 1944538
  • 1944543
  • 1944541
• UPC Code:
  • 0365597503106

Pharmacological Class

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

NDC Crossover Matching brand name "Roxybond" or generic name "Oxycodone Hydrochloride"

NDC	Brand Name	Generic Name
65597-502	Roxybond	Roxybond
65597-501	Roxybond	Roxybond
65597-503	Roxybond	Roxybond
0054-0390	oxycodone hydrochloride	oxycodone hydrochloride
0054-0393	Oxycodone Hydrochloride	Oxycodone Hydrochloride
0054-0522	Oxycodone Hydrochloride	Oxycodone Hydrochloride
0093-5731	Oxycodone Hydrochloride	Oxycodone Hydrochloride
0093-5732	Oxycodone Hydrochloride	Oxycodone Hydrochloride
0093-5733	Oxycodone Hydrochloride	Oxycodone Hydrochloride
0093-5734	Oxycodone Hydrochloride	Oxycodone Hydrochloride
0115-1556	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE
0115-1557	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE
0115-1558	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE
0115-1559	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE