FDA.reportPublic FDA data

SUBSYS

Product NDC
20482-004
11-digit product format
204820004
Labeler code
20482
Product ID
20482-004_c185344a-1761-53e2-e053-2995a90a0038
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fentanyl
Dosage form
SPRAY
Route
SUBLINGUAL
Labeler
Insys Therapeutics, Inc.
Application
NDA202788
Marketing category
NDA
Marketing start
2012-03-13
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
20482-004-102023-01-30C16284748780-1f386c649-9b75-0266-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
20482-004-302023-01-30C16284748780-1f386c649-9b75-0266-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
20482-004-10SUBSYS10 in 1 CARTONSPRAY1021
20482-004-10SUBSYS1 in 1 BLISTER PACKSPRAY121
20482-004-30SUBSYS1 in 1 BLISTER PACKSPRAY121
20482-004-30SUBSYS30 in 1 CARTONSPRAY3021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
20482-004-01EA - Each20482-00448414f08-994a-4332-920d-ac8f1add650512013-02-11
20482-004-10EA - Each20482-004a6e6d1c7-860c-4412-a3f6-8880927716c612013-06-04
20482-004-30EA - Each20482-0045bbb78d7-6cbb-40fb-b552-101dfa0ed43712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENTANYLACTIVE INGREDIENTUF599785JZSUBSYS (FENTANYL) SPRAY [INSYS THERAPEUTICS, INC.]12
FENTANYLACTIVE MOIETYUF599785JZSUBSYS (FENTANYL) SPRAY [INSYS THERAPEUTICS, INC.]12
alcoholINACTIVE INGREDIENT3K9958V90MSUBSYS (FENTANYL) SPRAY [INSYS THERAPEUTICS, INC.]12
levomentholINACTIVE INGREDIENTBZ1R15MTK7SUBSYS (FENTANYL) SPRAY [INSYS THERAPEUTICS, INC.]12
propylene glycolINACTIVE INGREDIENT6DC9Q167V3SUBSYS (FENTANYL) SPRAY [INSYS THERAPEUTICS, INC.]12
waterINACTIVE INGREDIENT059QF0KO0RSUBSYS (FENTANYL) SPRAY [INSYS THERAPEUTICS, INC.]12
xylitolINACTIVE INGREDIENTVCQ006KQ1ESUBSYS (FENTANYL) SPRAY [INSYS THERAPEUTICS, INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
20482-004SUBSYS (FENTANYL) SPRAY [INSYS THERAPEUTICS, INC.]21Legacy NDC, 4 package rows20210506_18a413e9-11e0-4a8f-86c0-d33b37b7b771.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]BPCK18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1740010{2 (fentanyl 0.8 MG/ACTUAT Mucosal Spray [Subsys]) } Pack [Subsys 1600 MCG]BPCK18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1740007{2 (fentanyl 0.6 MG/ACTUAT Mucosal Spray) } PackGPCK18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1740009{2 (fentanyl 0.8 MG/ACTUAT Mucosal Spray) } PackGPCK18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237050fentaNYL 100 MCG/ACTUAT Mucosal SprayPSN18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1740007fentaNYL 1200 MCG (2 x 600 MCG/ACTUAT) Mucosal SprayPSN18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1740009fentaNYL 1600 MCG (2 x 800 MCG/ACTUAT) Mucosal SprayPSN18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237057fentaNYL 200 MCG/ACTUAT Mucosal SprayPSN18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237060fentaNYL 400 MCG/ACTUAT Mucosal SprayPSN18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237064fentaNYL 600 MCG/ACTUAT Mucosal SprayPSN18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237068fentaNYL 800 MCG/ACTUAT Mucosal SprayPSN18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237055Subsys 100 MCG/ACTUAT Mucosal SprayPSN18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1740008Subsys 1200 MCG (2 x 600 MCG/ACTUAT) Mucosal SprayPSN18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1740010Subsys 1600 MCG (2 x 800 MCG/ACTUAT) Mucosal SprayPSN18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237059Subsys 200 MCG/ACTUAT Sublingual SprayPSN18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237062Subsys 400 MCG/ACTUAT Mucosal SprayPSN18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237066Subsys 600 MCG/ACTUAT Mucosal SprayPSN18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237070Subsys 800 MCG/ACTUAT Mucosal SprayPSN18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237055fentanyl 0.1 MG/ACTUAT Mucosal Spray [Subsys]SBD18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237059fentanyl 0.2 MG/ACTUAT Mucosal Spray [Subsys]SBD18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237062fentanyl 0.4 MG/ACTUAT Mucosal Spray [Subsys]SBD18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237066fentanyl 0.6 MG/ACTUAT Mucosal Spray [Subsys]SBD18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237070fentanyl 0.8 MG/ACTUAT Mucosal Spray [Subsys]SBD18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237050fentanyl 0.1 MG/ACTUAT Mucosal SpraySCD18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237057fentanyl 0.2 MG/ACTUAT Mucosal SpraySCD18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237060fentanyl 0.4 MG/ACTUAT Mucosal SpraySCD18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237064fentanyl 0.6 MG/ACTUAT Mucosal SpraySCD18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237068fentanyl 0.8 MG/ACTUAT Mucosal SpraySCD18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237050fentanyl 0.1 MG/ACTUAT Sublingual SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237057fentanyl 0.2 MG/ACTUAT Sublingual SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237060fentanyl 0.4 MG/ACTUAT Sublingual SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237064fentanyl 0.6 MG/ACTUAT Sublingual SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237068fentanyl 0.8 MG/ACTUAT Sublingual SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237050fentanyl 100 MCG/ACTUAT Mucosal SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1740007fentanyl 1200 MCG (2 x 600 MCG/ACTUAT) Mucosal SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1740009fentaNYL 1600 MCG (2 x 800 MCG/ACTUAT) Mucosal SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237057fentanyl 200 MCG/ACTUAT Mucosal SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237060fentanyl 400 MCG/ACTUAT Mucosal SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237064fentanyl 600 MCG/ACTUAT Sublingual SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237068fentanyl 800 MCG/ACTUAT Mucosal SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237055Subsys 0.1 MG/ACTUAT Mucosal SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237059Subsys 0.2 MG/ACTUAT Mucosal SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237062Subsys 0.4 MG/ACTUAT Mucosal SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237066Subsys 0.6 MG/ACTUAT Mucosal SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237070Subsys 0.8 MG/ACTUAT Mucosal SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237055Subsys 100 MCG/ACTUAT Sublingual SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1740008Subsys 1200 MCG (2 x 600 MCG/ACTUAT) Mucosal SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1740010Subsys 1600 MCG (2 x 800 MCG/ACTUAT) Mucosal SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237059Subsys 200 MCG/ACTUAT Sublingual SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237062Subsys 400 MCG/ACTUAT Sublingual SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237066Subsys 600 MCG/ACTUAT Sublingual SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121
1237070Subsys 800 MCG/ACTUAT Sublingual SpraySY18a413e9-11e0-4a8f-86c0-d33b37b7b77121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
20482-004-102048200041010 BLISTER PACK in 1 CARTON (20482-004-10) > 1 BOTTLE, SPRAY in 1 BLISTER PACK > 1 SPRAY in 1 BOTTLE, SPRAY10 blister pack2012-03-130000-00-00NoNoCurrent
20482-004-302048200043030 BLISTER PACK in 1 CARTON (20482-004-30) > 1 BOTTLE, SPRAY in 1 BLISTER PACK > 1 SPRAY in 1 BOTTLE, SPRAY30 blister pack2012-03-130000-00-00NoNoCurrent