NDC 0641-6027

Fentanyl Citrate

Fentanyl Citrate

Fentanyl Citrate is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Fentanyl Citrate.

Product ID0641-6027_4b400dd8-b922-442a-803d-5488003c1d0d
NDC0641-6027
Product TypeHuman Prescription Drug
Proprietary NameFentanyl Citrate
Generic NameFentanyl Citrate
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date1984-07-11
Marketing CategoryNDA / NDA
Application NumberNDA019101
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameFENTANYL CITRATE
Active Ingredient Strength50 ug/mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0641-6027-25

25 VIAL in 1 CARTON (0641-6027-25) > 2 mL in 1 VIAL (0641-6027-01)
Marketing Start Date1984-07-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0641-6027-25 [00641602725]

Fentanyl Citrate INJECTION
Marketing CategoryNDA
Application NumberNDA019101
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1984-07-11

NDC 0641-6027-01 [00641602701]

Fentanyl Citrate INJECTION
Marketing CategoryNDA
Application NumberNDA019101
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1984-07-11

Drug Details

Active Ingredients

IngredientStrength
FENTANYL CITRATE50 ug/mL

OpenFDA Data

SPL SET ID:ce5db1c2-feb1-4ad2-847a-d02e865bd47e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1735007
  • 1735013
  • 1735003
  • 1735008

    • 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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