NDC 67877-625

Oxycodone

Oxycodone

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

Product ID67877-625_84ec86c9-7b3d-40ee-b693-da0612250636
NDC67877-625
Product TypeHuman Prescription Drug
Proprietary NameOxycodone
Generic NameOxycodone
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2019-02-06
Marketing CategoryANDA / ANDA
Application NumberANDA211749
Labeler NameAscend Laboratories, LLC
Substance NameOXYCODONE HYDROCHLORIDE
Active Ingredient Strength100 mg/5mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67877-625-19

1 BOTTLE, PLASTIC in 1 CARTON (67877-625-19) > 15 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2019-02-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67877-625-59 [67877062559]

Oxycodone SOLUTION
Marketing CategoryANDA
Application NumberANDA211749
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-06

NDC 67877-625-19 [67877062519]

Oxycodone SOLUTION
Marketing CategoryANDA
Application NumberANDA211749
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-06

Drug Details

Active Ingredients

IngredientStrength
OXYCODONE HYDROCHLORIDE100 mg/5mL

OpenFDA Data

SPL SET ID:cc09aa92-98fc-4a01-a901-03903a97f46e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049615
    • UPC Code
  • 0367877625195
  • 0367877625591

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    67877-623OxycodoneOxycodone
    67877-625OxycodoneOxycodone
    0904-6966Oxycodone HydrochlorideOxycodone
    0904-7180Oxycodone HydrochlorideOxycodone
    65162-047Oxycodone HydrochlorideOxycodone
    65162-048Oxycodone HydrochlorideOxycodone
    65162-049Oxycodone HydrochlorideOxycodone
    65162-050Oxycodone HydrochlorideOxycodone
    65162-051Oxycodone HydrochlorideOxycodone
    68071-5055Oxycodone HydrochlorideOxycodone
    24510-110XTAMPZAOXYCODONE
    24510-115XTAMPZAOXYCODONE
    24510-120XTAMPZAOXYCODONE
    24510-130XTAMPZAOXYCODONE
    24510-140XTAMPZAOXYCODONE
    55700-557XTAMPZAOXYCODONE
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.