NDC 13913-010

Lazanda

Fentanyl Citrate

Lazanda is a Nasal Spray in the Human Prescription Drug category. It is labeled and distributed by Depomed, Inc.. The primary component is Fentanyl Citrate.

Product ID13913-010_c2b4b455-fd85-4767-baee-4d068f08e4e7
NDC13913-010
Product TypeHuman Prescription Drug
Proprietary NameLazanda
Generic NameFentanyl Citrate
Dosage FormSpray
Route of AdministrationNASAL
Marketing Start Date2011-10-17
Marketing CategoryNDA / NDA
Application NumberNDA022569
Labeler NameDepomed, Inc.
Substance NameFENTANYL CITRATE
Active Ingredient Strength400 ug/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 13913-010-01

1 BOTTLE, SPRAY in 1 CARTON (13913-010-01) > 8 SPRAY in 1 BOTTLE, SPRAY
Marketing Start Date2011-10-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13913-010-01 [13913001001]

Lazanda SPRAY
Marketing CategoryNDA
Application NumberNDA022569
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-10-17

NDC 13913-010-04 [13913001004]

Lazanda SPRAY
Marketing CategoryNDA
Application NumberNDA022569
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-10-17
Marketing End Date2015-01-12

Drug Details

Active Ingredients

IngredientStrength
FENTANYL CITRATE400 ug/1

OpenFDA Data

SPL SET ID:9dcaff31-1653-11e3-8ffd-0800200c9a66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1729322
  • 1729320
  • 1115579
  • 1115577
  • 1115575
  • 1115573
  • UPC Code
  • 0313913010012
  • 0313913009016
  • 0313913013013
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Lazanda" or generic name "Fentanyl Citrate"

    NDCBrand NameGeneric Name
    71500-140LazandaLazanda
    71500-110LazandaLazanda
    71500-130LazandaLazanda
    13913-010LazandaLazanda
    13913-013LazandaLazanda
    13913-009LazandaLazanda
    51772-314LAZANDALAZANDA
    51772-311LAZANDALAZANDA
    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

    Trademark Results [Lazanda]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LAZANDA
    LAZANDA
    85302528 4104596 Live/Registered
    BTCP PHARMA, LLC
    2011-04-22
    LAZANDA
    LAZANDA
    85196387 not registered Dead/Abandoned
    Archimedes Development Limited
    2010-12-13
    LAZANDA
    LAZANDA
    85196378 4068538 Live/Registered
    BTCP PHARMA, LLC
    2010-12-13

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