NDC 20482-016

SUBSYS

Fentanyl

SUBSYS is a Sublingual Spray in the Human Prescription Drug category. It is labeled and distributed by Insys Therapeutics, Inc.. The primary component is Fentanyl.

Product ID20482-016_97f180f5-d865-8c33-e053-2995a90ad465
NDC20482-016
Product TypeHuman Prescription Drug
Proprietary NameSUBSYS
Generic NameFentanyl
Dosage FormSpray
Route of AdministrationSUBLINGUAL
Marketing Start Date2012-08-30
Marketing CategoryNDA / NDA
Application NumberNDA202788
Labeler NameInsys Therapeutics, Inc.
Substance NameFENTANYL
Active Ingredient Strength1 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 20482-016-15

15 BLISTER PACK in 1 CARTON (20482-016-15) > 2 BOTTLE, SPRAY in 1 BLISTER PACK > 1 SPRAY in 1 BOTTLE, SPRAY
Marketing Start Date2012-08-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 20482-016-30 [20482001630]

SUBSYS SPRAY
Marketing CategoryNDA
Application NumberNDA202788
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-30
Marketing End Date2013-05-08

NDC 20482-016-15 [20482001615]

SUBSYS SPRAY
Marketing CategoryNDA
Application NumberNDA202788
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-30

Drug Details

Active Ingredients

IngredientStrength
FENTANYL.8 mg/1

OpenFDA Data

SPL SET ID:18a413e9-11e0-4a8f-86c0-d33b37b7b771
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1237060
  • 1740010
  • 1237059
  • 1740007
  • 1237068
  • 1237057
  • 1740009
  • 1740008
  • 1237064
  • 1237050
  • 1237066
  • 1237055
  • 1237062
  • 1237070
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    20482-001SUBSYSfentanyl
    20482-002SUBSYSfentanyl
    20482-012SUBSYSSUBSYS
    20482-006SUBSYSSUBSYS
    20482-008SUBSYSSUBSYS
    20482-004SUBSYSSUBSYS
    20482-016SUBSYSSUBSYS
    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

    Trademark Results [SUBSYS]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SUBSYS
    SUBSYS
    85094244 4143369 Live/Registered
    INSYS DEVELOPMENT COMPANY, INC.
    2010-07-27

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