NDC 17478-031

FENTANYL CITRATE

Fentanyl Citrate

FENTANYL CITRATE is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Akorn. The primary component is Fentanyl Citrate.

Product ID17478-031_3ca82edc-bb08-42b7-add5-e23c2c82cb44
NDC17478-031
Product TypeHuman Prescription Drug
Proprietary NameFENTANYL CITRATE
Generic NameFentanyl Citrate
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-07-10
Marketing CategoryNDA / NDA
Application NumberNDA016619
Labeler NameAkorn
Substance NameFENTANYL CITRATE
Active Ingredient Strength50 ug/mL
Pharm ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 17478-031-50

1 VIAL, SINGLE-DOSE in 1 CARTON (17478-031-50) > 50 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2017-07-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17478-031-50 [17478003150]

FENTANYL CITRATE INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA016619
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-10

Drug Details

Active Ingredients

IngredientStrength
FENTANYL CITRATE50 ug/mL

OpenFDA Data

SPL SET ID:c5d40297-b769-48cc-9f84-f98b7a333507
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1735007
  • 1735006
  • 1735013
  • 1735003
  • 1735008
  • UPC Code
  • 0317478031505
  • 0317478030027
  • Pharmacological Class

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

    NDC Crossover Matching brand name "FENTANYL CITRATE" or generic name "Fentanyl Citrate"

    NDCBrand NameGeneric Name
    0093-7865Fentanyl CitrateFentanyl Citrate
    0093-7866Fentanyl CitrateFentanyl Citrate
    0093-7867Fentanyl CitrateFentanyl Citrate
    0093-7868Fentanyl CitrateFentanyl Citrate
    0093-7869Fentanyl CitrateFentanyl Citrate
    0093-7870Fentanyl CitrateFentanyl Citrate
    0406-9202FENTANYL CITRATEFENTANYL CITRATE
    0409-9093FENTANYL CITRATEFENTANYL CITRATE
    0409-9094Fentanyl CitrateFentanyl Citrate
    0641-6024Fentanyl CitrateFentanyl Citrate
    0641-6026Fentanyl CitrateFentanyl Citrate
    0641-6028Fentanyl CitrateFentanyl Citrate
    0641-6029Fentanyl CitrateFentanyl Citrate
    0641-6030Fentanyl CitrateFentanyl Citrate
    0641-6025Fentanyl CitrateFentanyl Citrate
    0641-6027Fentanyl CitrateFentanyl Citrate
    17478-030FENTANYL CITRATEFENTANYL CITRATE
    17478-031FENTANYL CITRATEFENTANYL CITRATE
    52533-074Fentanyl CitrateFentanyl Citrate
    52533-025Fentanyl CitrateFentanyl Citrate
    52533-214FENTANYL CITRATEFENTANYL CITRATE
    0406-9216FENTANYL CITRATEFENTANYL CITRATE
    0406-9204FENTANYL CITRATEFENTANYL CITRATE
    0406-9206FENTANYL CITRATEFENTANYL CITRATE
    0406-9208FENTANYL CITRATEFENTANYL CITRATE
    0406-9212FENTANYL CITRATEFENTANYL CITRATE
    0409-1276Fentanyl CitrateFentanyl Citrate
    63323-806Fentanyl CitrateFentanyl Citrate

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