NDC Code(s) : 16714-115-01, 16714-115-02, 16714-116-01, 16714-116-02, 16714-117-01, 16714-117-02
Packager : Northstar Rx LLC.

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:16714-115
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:16714-115-0230 in 1 CARTON 10/01/2019
1NDC:16714-115-0124 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 10/01/2019
RivastigmineRivastigmine PATCH, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-116
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:16714-116-0230 in 1 CARTON 10/01/2019
1NDC:16714-116-0124 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 10/01/2019
RivastigmineRivastigmine PATCH, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-117
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:16714-117-0230 in 1 CARTON 10/01/2019
1NDC:16714-117-0124 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 10/01/2019

LABELER - Northstar Rx LLC.(830546433)

REGISTRANT - Zydus Pharmaceuticals USA Inc.(156861945)

Establishment
Name Address ID/FEI Business Operations
Zydus Lifesciences Limited 650461283 ANALYSIS(16714-115, 16714-116, 16714-117), MANUFACTURE(16714-115, 16714-116, 16714-117)

PRINCIPAL DISPLAY PANEL

Package Label – 4.6 mg / 24 hours

Rx only

NDC 16714-115-02

Rivastigmine

Transdermal System

Each System Delivers 4.6 mg/24 hours

For Transdermal Use Only.

Contains 30 systems

NORTHSTAR®

Rivastigmine transdermal system

PRINCIPAL DISPLAY PANEL

Package Label – 9.5 mg / 24 hours

Rx only

NDC 16714-116-02

Rivastigmine

Transdermal System

Each System Delivers 9.5 mg/24 hours

For Transdermal Use Only.

Contains 30 systems

NORTHSTAR®

Rivastigmine transdermal system

PRINCIPAL DISPLAY PANEL

Package Label – 13.3 mg / 24 hours

Rx only

NDC 16714-117-02

Rivastigmine

Transdermal System

Each System Delivers 13.3 mg/24 hours

For Transdermal Use Only.

Contains 30 systems

NORTHSTAR®

Rivastigmine transdermal system