NDC 51991-897

Rivastigmine Transdermal System

Rivastigmine

Rivastigmine Transdermal System is a Transdermal Patch, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Breckenridge Pharmaceutical, Inc.. The primary component is Rivastigmine.

Product ID51991-897_186c7640-6d82-4258-a9c3-2f592a47bee7
NDC51991-897
Product TypeHuman Prescription Drug
Proprietary NameRivastigmine Transdermal System
Generic NameRivastigmine
Dosage FormPatch, Extended Release
Route of AdministrationTRANSDERMAL
Marketing Start Date2019-12-19
Marketing CategoryANDA / ANDA
Application NumberANDA209063
Labeler NameBreckenridge Pharmaceutical, Inc.
Substance NameRIVASTIGMINE
Active Ingredient Strength5 mg/24h
Pharm ClassesCholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 51991-897-30

30 POUCH in 1 CARTON (51991-897-30) > 1 PATCH in 1 POUCH (51991-897-99) > 24 h in 1 PATCH
Marketing Start Date2019-12-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51991-897-30 [51991089730]

Rivastigmine Transdermal System PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209063
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-12-19

NDC 51991-897-99 [51991089799]

Rivastigmine Transdermal System PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209063
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-12-19

Drug Details

Active Ingredients

IngredientStrength
RIVASTIGMINE4.6 mg/24h

Pharmacological Class

  • Cholinesterase Inhibitor [EPC]
  • Cholinesterase Inhibitors [MoA]

NDC Crossover Matching brand name "Rivastigmine Transdermal System" or generic name "Rivastigmine"

NDCBrand NameGeneric Name
47781-305Rivastigmine Transdermal SystemRivastigmine Transdermal System
47781-304Rivastigmine Transdermal SystemRivastigmine Transdermal System
47781-405Rivastigmine Transdermal SystemRivastigmine Transdermal System
51991-897Rivastigmine Transdermal SystemRivastigmine Transdermal System
51991-899Rivastigmine Transdermal SystemRivastigmine Transdermal System
51991-898Rivastigmine Transdermal SystemRivastigmine Transdermal System
72855-102Rivastigmine Transdermal SystemRivastigmine Transdermal System
72855-100Rivastigmine Transdermal SystemRivastigmine Transdermal System
72855-101Rivastigmine Transdermal SystemRivastigmine Transdermal System
63629-2066Rivastigmine Transdermal SystemRivastigmine Transdermal System
63629-2065Rivastigmine Transdermal SystemRivastigmine Transdermal System
63629-2064Rivastigmine Transdermal SystemRivastigmine Transdermal System
0078-0501Exelonrivastigmine
0078-0502Exelonrivastigmine
0078-0503Exelonrivastigmine
0378-9070Rivastigminerivastigmine
0378-9071Rivastigminerivastigmine
0378-9072Rivastigminerivastigmine
0781-7304Rivastigminerivastigmine
0781-7309Rivastigminerivastigmine
0781-7313Rivastigminerivastigmine
16714-115RivastigmineRivastigmine
16714-116RivastigmineRivastigmine

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.