FDA.reportPublic FDA data

SUBSYS

Product NDC
71500-002
11-digit product format
715000002
Labeler code
71500
Product ID
71500-002_c10a64fb-0dc8-b077-e053-2995a90a374f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fentanyl
Dosage form
SPRAY
Route
SUBLINGUAL
Labeler
West Therapeutics Development, LLC
Application
NDA202788
Marketing category
NDA
Marketing start
2021-03-10
Marketing end
0000-00-00
Substance
FENTANYL
Active strength
0 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77d14d2b-b9bf-4254-8dd6-c60dedb281d3Product name120231002
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
d9ff6610-5d2e-d5c8-8a19-867d4a1efb77Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71500-002-302023-01-30C16284748780-1f386c649-9e81-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SUBSYS safely and effectively. See full prescribing information for SUBSYS. SUBSYS®(fentanyl sublingual spray), CII Initial U.S. Approval: 1968

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71500-002-30SUBSYS30 in 1 CARTONSPRAY3023
71500-002-30SUBSYS1 in 1 BLISTER PACKSPRAY123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71500-002-30EA - Each71500-002a6098e95-8ed9-4959-8345-38b4c14c34ac12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71500-002SUBSYS (FENTANYL) SPRAY [WEST THERAPEUTICS DEVELOPMENT, LLC]23Legacy NDC, 2 package rows20210429_be7670d5-b88a-13bd-e053-2995a90a2f78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1740008{2 (fentanyl 0.6 MG/ACTUAT Mucosal Spray [Subsys]) } Pack [Subsys 1200 MCG]BPCKbe7670d5-b88a-13bd-e053-2995a90a2f7823
1740010{2 (fentanyl 0.8 MG/ACTUAT Mucosal Spray [Subsys]) } Pack [Subsys 1600 MCG]BPCKbe7670d5-b88a-13bd-e053-2995a90a2f7823
1740007{2 (fentanyl 0.6 MG/ACTUAT Mucosal Spray) } PackGPCKbe7670d5-b88a-13bd-e053-2995a90a2f7823
1740009{2 (fentanyl 0.8 MG/ACTUAT Mucosal Spray) } PackGPCKbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237050fentaNYL 100 MCG/ACTUAT Mucosal SprayPSNbe7670d5-b88a-13bd-e053-2995a90a2f7823
1740007fentaNYL 1200 MCG (2 x 600 MCG/ACTUAT) Mucosal SprayPSNbe7670d5-b88a-13bd-e053-2995a90a2f7823
1740009fentaNYL 1600 MCG (2 x 800 MCG/ACTUAT) Mucosal SprayPSNbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237057fentaNYL 200 MCG/ACTUAT Mucosal SprayPSNbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237060fentaNYL 400 MCG/ACTUAT Mucosal SprayPSNbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237064fentaNYL 600 MCG/ACTUAT Mucosal SprayPSNbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237068fentaNYL 800 MCG/ACTUAT Mucosal SprayPSNbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237055Subsys 100 MCG/ACTUAT Mucosal SprayPSNbe7670d5-b88a-13bd-e053-2995a90a2f7823
1740008Subsys 1200 MCG (2 x 600 MCG/ACTUAT) Mucosal SprayPSNbe7670d5-b88a-13bd-e053-2995a90a2f7823
1740010Subsys 1600 MCG (2 x 800 MCG/ACTUAT) Mucosal SprayPSNbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237059Subsys 200 MCG/ACTUAT Sublingual SprayPSNbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237062Subsys 400 MCG/ACTUAT Mucosal SprayPSNbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237066Subsys 600 MCG/ACTUAT Mucosal SprayPSNbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237070Subsys 800 MCG/ACTUAT Mucosal SprayPSNbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237055fentanyl 0.1 MG/ACTUAT Mucosal Spray [Subsys]SBDbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237059fentanyl 0.2 MG/ACTUAT Mucosal Spray [Subsys]SBDbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237062fentanyl 0.4 MG/ACTUAT Mucosal Spray [Subsys]SBDbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237066fentanyl 0.6 MG/ACTUAT Mucosal Spray [Subsys]SBDbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237070fentanyl 0.8 MG/ACTUAT Mucosal Spray [Subsys]SBDbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237050fentanyl 0.1 MG/ACTUAT Mucosal SpraySCDbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237057fentanyl 0.2 MG/ACTUAT Mucosal SpraySCDbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237060fentanyl 0.4 MG/ACTUAT Mucosal SpraySCDbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237064fentanyl 0.6 MG/ACTUAT Mucosal SpraySCDbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237068fentanyl 0.8 MG/ACTUAT Mucosal SpraySCDbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237050fentanyl 0.1 MG/ACTUAT Sublingual SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237057fentanyl 0.2 MG/ACTUAT Sublingual SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237060fentanyl 0.4 MG/ACTUAT Sublingual SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237064fentanyl 0.6 MG/ACTUAT Sublingual SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237068fentanyl 0.8 MG/ACTUAT Sublingual SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237050fentanyl 100 MCG/ACTUAT Mucosal SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823
1740007fentanyl 1200 MCG (2 x 600 MCG/ACTUAT) Mucosal SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823
1740009fentaNYL 1600 MCG (2 x 800 MCG/ACTUAT) Mucosal SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237057fentanyl 200 MCG/ACTUAT Mucosal SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237060fentanyl 400 MCG/ACTUAT Mucosal SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237064fentanyl 600 MCG/ACTUAT Sublingual SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237068fentanyl 800 MCG/ACTUAT Mucosal SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237055Subsys 0.1 MG/ACTUAT Mucosal SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237059Subsys 0.2 MG/ACTUAT Mucosal SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237062Subsys 0.4 MG/ACTUAT Mucosal SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237066Subsys 0.6 MG/ACTUAT Mucosal SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237070Subsys 0.8 MG/ACTUAT Mucosal SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237055Subsys 100 MCG/ACTUAT Sublingual SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823
1740008Subsys 1200 MCG (2 x 600 MCG/ACTUAT) Mucosal SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823
1740010Subsys 1600 MCG (2 x 800 MCG/ACTUAT) Mucosal SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237059Subsys 200 MCG/ACTUAT Sublingual SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237062Subsys 400 MCG/ACTUAT Sublingual SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237066Subsys 600 MCG/ACTUAT Sublingual SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823
1237070Subsys 800 MCG/ACTUAT Sublingual SpraySYbe7670d5-b88a-13bd-e053-2995a90a2f7823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71500-002-107150000021010 BLISTER PACK in 1 CARTON (71500-002-10) > 1 BOTTLE, SPRAY in 1 BLISTER PACK > 1 SPRAY in 1 BOTTLE, SPRAY10 blister pack2021-03-100000-00-00NoNoCurrent
71500-002-307150000023030 BLISTER PACK in 1 CARTON (71500-002-30) > 1 BOTTLE, SPRAY in 1 BLISTER PACK > 1 SPRAY in 1 BOTTLE, SPRAY30 blister pack2021-03-100000-00-00NoNoCurrent