NDC Code(s) : 51956-0001-1, 51956-0001-7, 51956-0002-1, 51956-0002-7, 51956-0003-1, 51956-0003-7
Packager : Zydus Lifesciences Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

RivastigmineRivastigmine PATCH, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51956-0001
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIVASTIGMINE(UNII: PKI06M3IW0)
(RIVASTIGMINE - UNII:PKI06M3IW0) 		RIVASTIGMINE4.6 mg in 24 h
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
LIGHT MINERAL OIL(UNII: N6K5787QVP)
POLYISOBUTYLENE (1100000 MW)(UNII: FLT10CH37X)
POLYISOBUTYLENE (55000 MW)(UNII: TQ77WR8A02)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51956-0001-730 in 1 CARTON 03/06/2019
1NDC:51956-0001-124 h in 1 POUCH Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206318 03/06/2019
RivastigmineRivastigmine PATCH, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51956-0002
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIVASTIGMINE(UNII: PKI06M3IW0)
(RIVASTIGMINE - UNII:PKI06M3IW0) 		RIVASTIGMINE9.5 mg in 24 h
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
LIGHT MINERAL OIL(UNII: N6K5787QVP)
POLYISOBUTYLENE (1100000 MW)(UNII: FLT10CH37X)
POLYISOBUTYLENE (55000 MW)(UNII: TQ77WR8A02)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51956-0002-730 in 1 CARTON 03/06/2019
1NDC:51956-0002-124 h in 1 POUCH Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206318 03/06/2019
RivastigmineRivastigmine PATCH, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51956-0003
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIVASTIGMINE(UNII: PKI06M3IW0)
(RIVASTIGMINE - UNII:PKI06M3IW0) 		RIVASTIGMINE13.3 mg in 24 h
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
LIGHT MINERAL OIL(UNII: N6K5787QVP)
POLYISOBUTYLENE (1100000 MW)(UNII: FLT10CH37X)
POLYISOBUTYLENE (55000 MW)(UNII: TQ77WR8A02)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51956-0003-730 in 1 CARTON 03/06/2019
1NDC:51956-0003-124 h in 1 POUCH Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206318 03/06/2019

LABELER - Zydus Lifesciences Limited(650461283)

REGISTRANT - Zydus Lifesciences Limited(650461283)

Establishment
Name Address ID/FEI Business Operations
Zydus Lifesciences Limited 650461283 ANALYSIS(51956-0001, 51956-0002, 51956-0003), MANUFACTURE(51956-0001, 51956-0002, 51956-0003)

PRINCIPAL DISPLAY PANEL

Rx only

NDC 51956-0001-7

Rivastigmine

Transdermal System

Each System Delivers 4.6 mg/24 hours

For Transdermal Use Only.

Contains 30 systems

zydus Pharmaceuticals USA

Rivastigmine transdermal system

Rx only

NDC 51956-0002-7

Rivastigmine

Transdermal System

Each System Delivers 9.5 mg/24 hours

For Transdermal Use Only.

Contains 30 Systems

zydus Pharmaceuticals USA

Rivastigmine transdermal system

Rx only

NDC 51956-0003-7

Rivastigmine

Transdermal System

Each System Delivers 13.3 mg/24 hours

For Transdermal Use Only.

Contains 30 Systems

zydus Pharmaceuticals USA

Rivastigmine transdermal system