NDC 0406-9216

FENTANYL CITRATE

Fentanyl Citrate

FENTANYL CITRATE is a Transmucosal Lozenge in the Human Prescription Drug category. It is labeled and distributed by Specgx Llc. The primary component is Fentanyl Citrate.

Product ID0406-9216_35959e1c-80ea-40d1-9558-83bb9bf4ac72
NDC0406-9216
Product TypeHuman Prescription Drug
Proprietary NameFENTANYL CITRATE
Generic NameFentanyl Citrate
Dosage FormLozenge
Route of AdministrationTRANSMUCOSAL
Marketing Start Date2010-01-15
Marketing CategoryANDA / ANDA
Application NumberANDA078907
Labeler NameSpecGx LLC
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 0406-9216-30

30 BLISTER PACK in 1 CARTON (0406-9216-30) > 1 LOZENGE in 1 BLISTER PACK
Marketing Start Date2009-10-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0406-9216-30 [00406921630]

FENTANYL CITRATE LOZENGE
Marketing CategoryANDA
Application NumberANDA078907
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-10-30

Drug Details

Active Ingredients

IngredientStrength
FENTANYL CITRATE1600 ug/1

OpenFDA Data

SPL SET ID:552ba162-76ed-4bc9-8c2c-fac7a1804da0
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

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