NDC 71500-016

SUBSYS

Fentanyl

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

Product ID71500-016_bcb74fed-6ce5-4724-e053-2995a90aa66a
NDC71500-016
Product TypeHuman Prescription Drug
Proprietary NameSUBSYS
Generic NameFentanyl
Dosage FormSpray
Route of AdministrationSUBLINGUAL
Marketing Start Date2021-03-10
Marketing CategoryNDA /
Application NumberNDA202788
Labeler NameWest Therapeutics Development, LLC
Substance NameFENTANYL
Active Ingredient Strength1 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 71500-016-15

15 BLISTER PACK in 1 CARTON (71500-016-15) > 2 BOTTLE, SPRAY in 1 BLISTER PACK > 1 SPRAY in 1 BOTTLE, SPRAY
Marketing Start Date2021-03-10
NDC Exclude FlagN
Sample Package?N

Drug Details

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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