NDC 17478-050

Sufentanil Citrate

Sufentanil Citrate

Sufentanil Citrate is a Epidural; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Akorn. The primary component is Sufentanil Citrate.

Product ID17478-050_2b2b98f6-225d-4d67-80f5-720e65051478
NDC17478-050
Product TypeHuman Prescription Drug
Proprietary NameSufentanil Citrate
Generic NameSufentanil Citrate
Dosage FormInjection
Route of AdministrationEPIDURAL; INTRAVENOUS
Marketing Start Date2010-12-01
Marketing CategoryNDA / NDA
Application NumberNDA019050
Labeler NameAkorn
Substance NameSUFENTANIL 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 17478-050-01

10 AMPULE in 1 CARTON (17478-050-01) > 1 mL in 1 AMPULE
Marketing Start Date2010-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17478-050-01 [17478005001]

Sufentanil Citrate INJECTION
Marketing CategoryNDA
Application NumberNDA019050
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-12-01

NDC 17478-050-02 [17478005002]

Sufentanil Citrate INJECTION
Marketing CategoryNDA
Application NumberNDA019050
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-12-01

NDC 17478-050-05 [17478005005]

Sufentanil Citrate INJECTION
Marketing CategoryNDA
Application NumberNDA019050
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-12-01

Drug Details

Active Ingredients

IngredientStrength
SUFENTANIL CITRATE50 ug/mL

OpenFDA Data

SPL SET ID:95e639db-1ca3-4328-b347-7ea348f6cc72
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1809097
  • 1809102
  • 1809104
  • UPC Code
  • 0317478050018
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Sufentanil Citrate" or generic name "Sufentanil Citrate"

    NDCBrand NameGeneric Name
    0409-3382Sufentanil CitrateSUFENTANIL CITRATE
    0641-6110Sufentanil CitrateSufentanil Citrate
    0641-6111Sufentanil CitrateSufentanil Citrate
    0641-6112Sufentanil CitrateSufentanil Citrate
    17478-050Sufentanil CitrateSufentanil Citrate

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