NDC 63304-400

Oxycodone HCl Controlled-Release

Oxycodone Hcl Controlled-release

Oxycodone HCl Controlled-Release is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ranbaxy Pharmaceuticals Inc. The primary component is Oxycodone Hydrochloride.

• Product ID: 63304-400_88603d5f-4ad0-46ab-999f-740312dc35dc
• NDC: 63304-400
• Product Type: Human Prescription Drug
• Proprietary Name: Oxycodone HCl Controlled-Release
• Generic Name: Oxycodone Hcl Controlled-release
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2010-02-01
• Marketing Category: NDA / NDA
• Application Number: NDA020553
• Labeler Name: Ranbaxy Pharmaceuticals Inc
• Substance Name: OXYCODONE HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 63304-400-01

100 TABLET in 1 BOTTLE (63304-400-01)

• Marketing Start Date: 2010-02-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63304-400-01 [63304040001]

Oxycodone HCl Controlled-Release TABLET

• Marketing Category: NDA
• Application Number: NDA020553
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-02-01
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
OXYCODONE HYDROCHLORIDE	10 mg/1

OpenFDA Data

• SPL SET ID: 88603d5f-4ad0-46ab-999f-740312dc35dc
• Manufacturer:
  • Ranbaxy Pharmaceuticals Inc
• UNII:
  • C1ENJ2TE6C
• RxNorm Concept Unique ID - RxCUI:
  • 1049502
  • 1049563
• UPC Code:
  • 0363304401011
  • 0363304400014

Pharmacological Class

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

NDC Crossover Matching brand name "Oxycodone HCl Controlled-Release" or generic name "Oxycodone Hcl Controlled-release"

NDC	Brand Name	Generic Name
63304-400	Oxycodone HCl Controlled-Release	Oxycodone HCl Controlled-Release
63304-401	Oxycodone HCl Controlled-Release	Oxycodone HCl Controlled-Release