NDC 0093-7870

Fentanyl Citrate

Fentanyl Citrate

Fentanyl Citrate is a Oral; Transmucosal Lozenge in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Fentanyl Citrate.

Product ID0093-7870_38b8be2b-96c4-4b49-8782-90df4508906e
NDC0093-7870
Product TypeHuman Prescription Drug
Proprietary NameFentanyl Citrate
Generic NameFentanyl Citrate
Dosage FormLozenge
Route of AdministrationORAL; TRANSMUCOSAL
Marketing Start Date2015-12-08
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA020747
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameFENTANYL CITRATE
Active Ingredient Strength1600 ug/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0093-7870-65

30 BLISTER PACK in 1 CARTON (0093-7870-65) > 1 LOZENGE in 1 BLISTER PACK (0093-7870-19)
Marketing Start Date2015-12-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-7870-65 [00093787065]

Fentanyl Citrate LOZENGE
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA020747
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-08

NDC 0093-7870-19 [00093787019]

Fentanyl Citrate LOZENGE
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA020747
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-08

Drug Details

Active Ingredients

IngredientStrength
FENTANYL CITRATE1600 ug/1

OpenFDA Data

SPL SET ID:78221eab-66fd-4cd8-9c81-af52eb83671c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310293
  • 310297
  • 310295
  • 313993
  • 313992
  • 310294

    • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.