NDC 0121-4827

OXYCODONE HYDROCHLORIDE

Oxycodone Hydrochloride

OXYCODONE HYDROCHLORIDE is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Pharmaceutical Associates, Inc.. The primary component is Oxycodone Hydrochloride.

Product ID0121-4827_860b997c-a75f-c913-e053-2a91aa0a2070
NDC0121-4827
Product TypeHuman Prescription Drug
Proprietary NameOXYCODONE HYDROCHLORIDE
Generic NameOxycodone Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2019-04-08
Marketing CategoryANDA / ANDA
Application NumberANDA206914
Labeler NamePharmaceutical Associates, Inc.
Substance NameOXYCODONE HYDROCHLORIDE
Active Ingredient Strength5 mg/5mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0121-4827-40

4 TRAY in 1 CASE (0121-4827-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-4827-05)
Marketing Start Date2019-04-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0121-4827-05 [00121482705]

OXYCODONE HYDROCHLORIDE SOLUTION
Marketing CategoryANDA
Application NumberANDA206914
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-04-08

NDC 0121-4827-50 [00121482750]

OXYCODONE HYDROCHLORIDE SOLUTION
Marketing CategoryANDA
Application NumberANDA206914
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2020-02-27

NDC 0121-4827-40 [00121482740]

OXYCODONE HYDROCHLORIDE SOLUTION
Marketing CategoryANDA
Application NumberANDA206914
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-04-08

Drug Details

Active Ingredients

IngredientStrength
OXYCODONE HYDROCHLORIDE5 mg/5mL

OpenFDA Data

SPL SET ID:73b063b5-24b7-40bf-bc2a-c0e1bfaf61d1
Manufacturer
UNII

Pharmacological Class

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

NDC Crossover Matching brand name "OXYCODONE HYDROCHLORIDE" or generic name "Oxycodone Hydrochloride"

NDCBrand NameGeneric Name
0054-0390oxycodone hydrochlorideoxycodone hydrochloride
0054-0393Oxycodone HydrochlorideOxycodone Hydrochloride
0054-0522Oxycodone HydrochlorideOxycodone Hydrochloride
0093-5731Oxycodone HydrochlorideOxycodone Hydrochloride
0093-5732Oxycodone HydrochlorideOxycodone Hydrochloride
0093-5733Oxycodone HydrochlorideOxycodone Hydrochloride
0093-5734Oxycodone HydrochlorideOxycodone Hydrochloride
0115-1556OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
0115-1557OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
0115-1558OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
0115-1559OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
68084-184Oxycodone HydrochlorideOxycodone Hydrochloride
68084-354OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
68084-185Oxycodone HydrochlorideOxycodone Hydrochloride
68094-801Oxycodone HydrochlorideOxycodone Hydrochloride
68084-975OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
68084-828Oxycodone HydrochlorideOxycodone Hydrochloride
68084-048Oxycodone HydrochlorideOxycodone Hydrochloride
68084-983OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
68084-968OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
68094-005Oxycodone HydrochlorideOxycodone Hydrochloride
68308-108Oxycodone HydrochlorideOxycodone Hydrochloride
68308-020Oxycodone HydrochlorideOxycodone Hydrochloride
68308-505Oxycodone HydrochlorideOxycodone Hydrochloride
68308-120Oxycodone HydrochlorideOxycodone Hydrochloride
68308-111Oxycodone HydrochlorideOxycodone Hydrochloride
68308-145Oxycodone HydrochlorideOxycodone Hydrochloride
68308-110Oxycodone HydrochlorideOxycodone Hydrochloride
68308-112Oxycodone HydrochlorideOxycodone Hydrochloride
68382-793OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
68382-795OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
68382-794OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
68382-797OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
68382-796OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
68462-204Oxycodone HydrochlorideOxycodone Hydrochloride
68462-347Oxycodone HydrochlorideOxycodone Hydrochloride
0527-1774Oxycodone HydrochlorideOxycodone Hydrochloride
0527-1426Oxycodone HydrochlorideOxycodone Hydrochloride
70166-492Oxycodone HydrochlorideOxycodone Hydrochloride
0591-2693Oxycodone HydrochlorideOxycodone Hydrochloride
0591-2708Oxycodone HydrochlorideOxycodone Hydrochloride
0603-4991Oxycodone HydrochlorideOxycodone Hydrochloride
0603-4992Oxycodone HydrochlorideOxycodone Hydrochloride
0603-4994Oxycodone HydrochlorideOxycodone Hydrochloride
0603-4990Oxycodone HydrochlorideOxycodone Hydrochloride
0603-4993Oxycodone HydrochlorideOxycodone Hydrochloride
71335-0677Oxycodone HydrochlorideOxycodone Hydrochloride
71335-0174OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE
71335-1023Oxycodone HydrochlorideOxycodone Hydrochloride
71335-0209OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE

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