FDA.reportPublic FDA data

LAZANDA

Product NDC
51772-314
11-digit product format
517720314
Labeler code
51772
Product ID
51772-314_ec21fe5a-b1f8-405e-9d75-6c01a24c9e51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fentanyl Citrate
Dosage form
SPRAY
Route
NASAL
Labeler
Archimedes Pharma US Inc.
Application
NDA022569
Marketing category
NDA
Marketing start
2011-10-17
Marketing end
0000-00-00
Substance
FENTANYL CITRATE
Active strength
400 ug/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77d14d2b-b9bf-4254-8dd6-c60dedb281d3Product name120231002
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
a8df478d-5b88-9654-981b-87dff14dda8bProduct name220190801
e9b48db2-e05b-8c2d-e4ac-a5a2efb26b57Product name220180118
bb365072-425e-ca0a-021e-fd8b78162502Product name220161228
339915c8-cc8f-ceb4-1d3f-5ea267d21ea6Product name220160104
739fa0ac-b690-63c4-9904-e20dffbf78f9Product name120140508
7763fcbb-367d-ed06-b37f-e1529b6241beProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
d9ff6610-5d2e-d5c8-8a19-867d4a1efb77Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51772-314-012020-01-31C16284748780-19d75b9cf-d793-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LAZANDA safely and effectively. See full prescribing information for LAZANDA Lazanda ® (Fentanyl) Nasal Spray CII Initial U.S. Approval: 1968
51772-314-042020-01-31C16284748780-19d75b9cf-d793-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LAZANDA safely and effectively. See full prescribing information for LAZANDA Lazanda ® (Fentanyl) Nasal Spray CII Initial U.S. Approval: 1968

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51772-314-01LAZANDA8 in 1 BOTTLE, SPRAYSPRAY85
51772-314-01LAZANDA1 in 1 CARTONSPRAY15
51772-314-04LAZANDA4 in 1 CARTONSPRAY45
51772-314-04LAZANDA8 in 1 BOTTLE, SPRAYSPRAY85

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51772-314-01EA - Each51772-314cef58cba-54dd-4ef6-ba59-6f33ffb98d9412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Fentanyl CitrateACTIVE INGREDIENTMUN5LYG46HLAZANDA (FENTANYL CITRATE) SPRAY [ARCHIMEDES PHARMA US INC.]5
FentanylACTIVE MOIETYUF599785JZLAZANDA (FENTANYL CITRATE) SPRAY [ARCHIMEDES PHARMA US INC.]5
MannitolINACTIVE INGREDIENT3OWL53L36ALAZANDA (FENTANYL CITRATE) SPRAY [ARCHIMEDES PHARMA US INC.]5
PectinINACTIVE INGREDIENT89NA02M4RXLAZANDA (FENTANYL CITRATE) SPRAY [ARCHIMEDES PHARMA US INC.]5
Phenylethyl alcoholINACTIVE INGREDIENTML9LGA7468LAZANDA (FENTANYL CITRATE) SPRAY [ARCHIMEDES PHARMA US INC.]5
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHLAZANDA (FENTANYL CITRATE) SPRAY [ARCHIMEDES PHARMA US INC.]5
SucroseINACTIVE INGREDIENTC151H8M554LAZANDA (FENTANYL CITRATE) SPRAY [ARCHIMEDES PHARMA US INC.]5
WaterINACTIVE INGREDIENT059QF0KO0RLAZANDA (FENTANYL CITRATE) SPRAY [ARCHIMEDES PHARMA US INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51772-314LAZANDA (FENTANYL CITRATE) SPRAY [ARCHIMEDES PHARMA US INC.]5Legacy NDC, 4 package rows20120801_39531d0c-db12-4627-81c9-6563076b637b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115573fentaNYL 100 MCG/ACTUAT Metered Dose Nasal SprayPSN39531d0c-db12-4627-81c9-6563076b637b5
1115577fentaNYL 400 MCG/ACTUAT Metered Dose Nasal SprayPSN39531d0c-db12-4627-81c9-6563076b637b5
1115575Lazanda 100 MCG/ACTUAT Metered Dose Nasal SprayPSN39531d0c-db12-4627-81c9-6563076b637b5
1115579Lazanda 400 MCG/ACTUAT Metered Dose Nasal SprayPSN39531d0c-db12-4627-81c9-6563076b637b5
1115575fentanyl 0.1 MG/ACTUAT Metered Dose Nasal Spray [Lazanda]SBD39531d0c-db12-4627-81c9-6563076b637b5
1115579fentanyl 0.4 MG/ACTUAT Metered Dose Nasal Spray [Lazanda]SBD39531d0c-db12-4627-81c9-6563076b637b5
1115573fentanyl 0.1 MG/ACTUAT Metered Dose Nasal SpraySCD39531d0c-db12-4627-81c9-6563076b637b5
1115577fentanyl 0.4 MG/ACTUAT Metered Dose Nasal SpraySCD39531d0c-db12-4627-81c9-6563076b637b5
1115573fentanyl (as fentanyl citrate) 100 MCG/ACTUAT Metered Dose Nasal SpraySY39531d0c-db12-4627-81c9-6563076b637b5
1115577fentanyl (as fentanyl citrate) 400 MCG/ACTUAT Metered Dose Nasal SpraySY39531d0c-db12-4627-81c9-6563076b637b5
1115575Lazanda 0.1 MG/ACTUAT Metered Dose Nasal SpraySY39531d0c-db12-4627-81c9-6563076b637b5
1115579Lazanda 0.4 MG/ACTUAT Metered Dose Nasal SpraySY39531d0c-db12-4627-81c9-6563076b637b5
1115575Lazanda 100 MCG/ACTUAT Metered Dose Nasal SpraySY39531d0c-db12-4627-81c9-6563076b637b5
1115579Lazanda 400 MCG/ACTUAT Metered Dose Nasal SpraySY39531d0c-db12-4627-81c9-6563076b637b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
51772-314-01517720314018 in 1 BOTTLE, SPRAYHistorical
51772-314-04517720314044 in 1 CARTONHistorical