NDC 71500-130

Lazanda

Fentanyl

Lazanda is a Nasal Aerosol, Spray in the Human Prescription Drug category. It is labeled and distributed by West Therapeutic Development Llc. The primary component is Fentanyl Citrate.

Product ID71500-130_73f38bde-2133-2b5a-e053-2a91aa0a6efb
NDC71500-130
Product TypeHuman Prescription Drug
Proprietary NameLazanda
Generic NameFentanyl
Dosage FormAerosol, Spray
Route of AdministrationNASAL
Marketing Start Date2018-08-25
Marketing CategoryNDA / NDA
Application NumberNDA022569
Labeler NameWest Therapeutic Development LLC
Substance NameFENTANYL CITRATE
Active Ingredient Strength300 ug/81
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71500-130-01

1 BOTTLE, SPRAY in 1 CARTON (71500-130-01) > 8 SPRAY in 1 BOTTLE, SPRAY
Marketing Start Date2018-08-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71500-130-01 [71500013001]

LAZANDA SPRAY
Marketing CategoryNDA
Application NumberNDA022569
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-25

Drug Details

Active Ingredients

IngredientStrength
FENTANYL CITRATE300 ug/81

OpenFDA Data

SPL SET ID:73f38bde-2132-2b5a-e053-2a91aa0a6efb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1729322
  • 1729320
  • 1115579
  • 1115577
  • 1115575
  • 1115573
  • UPC Code
  • 0371500140016
  • 0371500110019
  • 0371500130017
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    13913-009Lazandafentanyl citrate
    13913-010Lazandafentanyl citrate
    13913-013Lazandafentanyl citrate
    71500-140LazandaLazanda
    71500-110LazandaLazanda
    71500-130LazandaLazanda
    51772-314LAZANDALAZANDA
    51772-311LAZANDALAZANDA
    0378-9119FENTANYLFENTANYL
    0378-9121FENTANYLFENTANYL
    0378-9122FENTANYLFENTANYL
    0378-9123FENTANYLFENTANYL
    0378-9124FENTANYLFENTANYL
    0378-9125FENTANYLFENTANYL
    0378-9126FENTANYLFENTANYL
    0378-9127FENTANYLFENTANYL
    0591-3198FentanylFentanyl
    0591-3212FentanylFentanyl
    0591-3213FentanylFentanyl
    0591-3214FentanylFentanyl
    0781-7240FentanylFentanyl
    0781-7241FentanylFentanyl
    0781-7242FentanylFentanyl
    0781-7243FentanylFentanyl
    0781-7244FentanylFentanyl
    20482-001SUBSYSfentanyl
    20482-002SUBSYSfentanyl

    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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