NDC Code(s) : 0085-3305-30, 0085-3310-30, 0085-3310-35, 0085-3315-30, 0085-3315-35, 0085-3320-30, 0085-3320-35, 0085-3330-30, 0085-0819-30, 0085-0819-35
Packager : Merck Sharp & Dohme Corp.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NITRO-DURnitroglycerin PATCH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0085-3305
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
nitroglycerin(UNII: G59M7S0WS3)
(nitroglycerin - UNII:G59M7S0WS3) 		nitroglycerin20 mg
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0085-3305-3030 in 1 BOX, UNIT-DOSE
11 in 1 POUCH Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020145 04/04/1995
NITRO-DURnitroglycerin PATCH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0085-3310
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
nitroglycerin(UNII: G59M7S0WS3)
(nitroglycerin - UNII:G59M7S0WS3) 		nitroglycerin40 mg
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0085-3310-3030 in 1 BOX, UNIT-DOSE
11 in 1 POUCH Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0085-3310-3530 in 1 PACKAGE
21 in 1 POUCH Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020145 04/04/1995
NITRO-DURnitroglycerin PATCH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0085-3315
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
nitroglycerin(UNII: G59M7S0WS3)
(nitroglycerin - UNII:G59M7S0WS3) 		nitroglycerin60 mg
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0085-3315-3030 in 1 BOX, UNIT-DOSE
11 in 1 POUCH Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0085-3315-3530 in 1 PACKAGE
21 in 1 POUCH Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020145 04/04/1995
NITRO-DURnitroglycerin PATCH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0085-3320
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
nitroglycerin(UNII: G59M7S0WS3)
(nitroglycerin - UNII:G59M7S0WS3) 		nitroglycerin80 mg
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0085-3320-3030 in 1 BOX, UNIT-DOSE
11 in 1 POUCH Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0085-3320-3530 in 1 PACKAGE
21 in 1 POUCH Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020145 04/04/1995
NITRO-DURnitroglycerin PATCH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0085-3330
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
nitroglycerin(UNII: G59M7S0WS3)
(nitroglycerin - UNII:G59M7S0WS3) 		nitroglycerin120 mg
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0085-3330-3030 in 1 BOX, UNIT-DOSE
11 in 1 POUCH Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020145 04/04/1995
NITRO-DURnitroglycerin PATCH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0085-0819
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
nitroglycerin(UNII: G59M7S0WS3)
(nitroglycerin - UNII:G59M7S0WS3) 		nitroglycerin160 mg
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0085-0819-3030 in 1 BOX, UNIT-DOSE
11 in 1 POUCH Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0085-0819-3530 in 1 PACKAGE
21 in 1 POUCH Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020145 04/04/1995

PRINCIPAL DISPLAY PANEL

NDC 0085-3305-30
Contents: 30 units

Nitro-Dur ®
(nitroglycerin)
Transdermal Infusion System

0.1
mg/hr
(5 cm2)

Each unit contains 20 mg of
nitroglycerin in acrylic-based
polymer adhesives with a
resinous cross-linking agent.

Rated release in vivo 0.1 mg/hr.

Rx only

PRINCIPAL DISPLAY PANEL - 20 mg Pouch Box

PRINCIPAL DISPLAY PANEL

NDC 0085-3310-30
Contents: 30 units

Nitro-Dur ®
(nitroglycerin)
Transdermal Infusion System

0.2
mg/hr
(10 cm2)

Each unit contains 40 mg of
nitroglycerin in acrylic-based
polymer adhesives with a
resinous cross-linking agent.

Rated release in vivo 0.2 mg/hr.

Rx only

PRINCIPAL DISPLAY PANEL - 40 mg Pouch Box

PRINCIPAL DISPLAY PANEL

NDC 0085-3315-30
Contents: 30 units

Nitro-Dur ®
(nitroglycerin)
Transdermal Infusion System

0.3
mg/hr
(15 cm2)

Each unit contains 60 mg of
nitroglycerin in acrylic-based
polymer adhesives with a
resinous cross-linking agent.

Rated release in vivo 0.3 mg/hr.

Rx only

PRINCIPAL DISPLAY PANEL - 60 mg Pouch Box

PRINCIPAL DISPLAY PANEL

NDC 0085-3320-30
Contents: 30 units

Nitro-Dur ®
(nitroglycerin)
Transdermal Infusion System

0.4
mg/hr
(20 cm2)

Each unit contains 80 mg of
nitroglycerin in acrylic-based
polymer adhesives with a
resinous cross-linking agent.

Rated release in vivo 0.4 mg/hr.

Rx only

PRINCIPAL DISPLAY PANEL - 80 mg Pouch Box

PRINCIPAL DISPLAY PANEL

NDC 0085-3330-30
Contents: 30 units

Nitro-Dur ®
(nitroglycerin)
Transdermal Infusion System

0.6
mg/hr
(30 cm2)

Each unit contains 120 mg of
nitroglycerin in acrylic-based
polymer adhesives with a
resinous cross-linking agent.

Rated release in vivo 0.6 mg/hr.

Rx only

PRINCIPAL DISPLAY PANEL - 120 mg Pouch Box

PRINCIPAL DISPLAY PANEL

NDC 0085-0819-30
Contents: 30 units

Nitro-Dur ®
(nitroglycerin)
Transdermal Infusion System

0.8
mg/hr
(40 cm2)

Each unit contains 160 mg of
nitroglycerin in acrylic-based
polymer adhesives with a
resinous cross-linking agent.

Rated release in vivo 0.8 mg/hr.

Rx only

PRINCIPAL DISPLAY PANEL - 160 mg Pouch Box