NDC 0409-9093

Fentanyl Citrate

Fentanyl Citrate

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

Product ID0409-9093_060afea1-70bf-4295-82ff-0fbd65b819c8
NDC0409-9093
Product TypeHuman Prescription Drug
Proprietary NameFentanyl Citrate
Generic NameFentanyl Citrate
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2005-11-15
Marketing CategoryNDA / NDA
Application NumberNDA019115
Labeler NameHospira, Inc.
Substance NameFENTANYL CITRATE
Active Ingredient Strength50 ug/mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0409-9093-32

10 AMPULE in 1 CELLO PACK (0409-9093-32) > 2 mL in 1 AMPULE (0409-9093-37)
Marketing Start Date2005-11-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-9093-45 [00409909345]

FENTANYL CITRATE INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019115
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-02-24

NDC 0409-9093-41 [00409909341]

FENTANYL CITRATE INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019115
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-02-24

NDC 0409-9093-36 [00409909336]

FENTANYL CITRATE INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019115
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-07-20
Marketing End Date2011-09-01

NDC 0409-9093-37 [00409909337]

FENTANYL CITRATE INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019115
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-02-24

NDC 0409-9093-09 [00409909309]

FENTANYL CITRATE INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019115
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-12-06
Marketing End Date2020-04-01

NDC 0409-9093-11 [00409909311]

FENTANYL CITRATE INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019115
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-12-06
Marketing End Date2020-04-01

NDC 0409-9093-32 [00409909332]

FENTANYL CITRATE INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019115
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-11-15

NDC 0409-9093-31 [00409909331]

FENTANYL CITRATE INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019115
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-02-24

NDC 0409-9093-38 [00409909338]

FENTANYL CITRATE INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019115
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-03-01
Marketing End Date2018-09-01

NDC 0409-9093-35 [00409909335]

FENTANYL CITRATE INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019115
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-12-14

Drug Details

Active Ingredients

IngredientStrength
FENTANYL CITRATE50 ug/mL

OpenFDA Data

SPL SET ID:1ed25b2c-334e-4021-ada1-3396f07630dc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1735003

    • 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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