NDC 63323-806

Fentanyl Citrate

Fentanyl Citrate

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

Product ID63323-806_23c7a740-61c9-488d-8041-bbb2e85016ac
NDC63323-806
Product TypeHuman Prescription Drug
Proprietary NameFentanyl Citrate
Generic NameFentanyl Citrate
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2019-05-03
Marketing CategoryANDA / ANDA
Application NumberANDA210762
Labeler NameFresenius Kabi USA, LLC
Substance NameFENTANYL CITRATE
Active Ingredient Strength0 mg/mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 63323-806-01

25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-01) > 1 mL in 1 VIAL, SINGLE-DOSE (63323-806-11)
Marketing Start Date2019-05-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-806-12 [63323080612]

Fentanyl Citrate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210762
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-05-03

NDC 63323-806-50 [63323080650]

Fentanyl Citrate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210762
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-05-03

NDC 63323-806-01 [63323080601]

Fentanyl Citrate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210762
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-05-03

NDC 63323-806-14 [63323080614]

Fentanyl Citrate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210762
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-05-03

NDC 63323-806-02 [63323080602]

Fentanyl Citrate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210762
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-05-03

NDC 63323-806-13 [63323080613]

Fentanyl Citrate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210762
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-05-03

NDC 63323-806-11 [63323080611]

Fentanyl Citrate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210762
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-05-03

NDC 63323-806-05 [63323080605]

Fentanyl Citrate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210762
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-05-03

NDC 63323-806-20 [63323080620]

Fentanyl Citrate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210762
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-05-03

Drug Details

Active Ingredients

IngredientStrength
FENTANYL CITRATE.05 mg/mL

OpenFDA Data

SPL SET ID:38d0c14a-a0c1-44cc-a939-0304eb8037d6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1735007
  • 1735013
  • 1735003
  • 2168270
  • 1735008

    • Pharmacological Class

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