NDC 63304-401

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 ID63304-401_88603d5f-4ad0-46ab-999f-740312dc35dc
NDC63304-401
Product TypeHuman Prescription Drug
Proprietary NameOxycodone HCl Controlled-Release
Generic NameOxycodone Hcl Controlled-release
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-02-01
Marketing CategoryNDA / NDA
Application NumberNDA020553
Labeler NameRanbaxy Pharmaceuticals Inc
Substance NameOXYCODONE HYDROCHLORIDE
Active Ingredient Strength20 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 63304-401-01

100 TABLET in 1 BOTTLE (63304-401-01)
Marketing Start Date2010-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63304-401-01 [63304040101]

Oxycodone HCl Controlled-Release TABLET
Marketing CategoryNDA
Application NumberNDA020553
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-01
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
OXYCODONE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:88603d5f-4ad0-46ab-999f-740312dc35dc
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    63304-400Oxycodone HCl Controlled-ReleaseOxycodone HCl Controlled-Release
    63304-401Oxycodone HCl Controlled-ReleaseOxycodone HCl Controlled-Release
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