Nitroglycerin Transdermal Delivery System (Page 3 of 3)

PATIENT INSTRUCTIONS FOR APPLICATION OF SYSTEM

A patient leaflet is supplied with each carton.

HOW SUPPLIED

Nitroglycerin Transdermal Delivery SystemRatedReleaseIn Vivo

SystemSize TotalNitro-glycerinIn System NDCNumber
0.1 mg/hr 3.3 cm2 9 mg NDC-29336-321-30
0.2 mg/hr 6.7 cm2 18 mg NDC-29336-322-30
0.4 mg/hr 13.3 cm2 36 mg NDC-29336-323-30
0.6 mg/hr 20.0 cm2 54 mg NDC-29336-324-30

Nitroglycerin Transdermal Delivery System, 0.1 mg/hr, 0.2 mg/hr, 0.4 mg/hr, 0.6 mg/hr is available in cartons of 30 patches.

STORAGE CONDITIONS

Store at controlled room temperature 15°-30°C (59°-86°F). Extremes of temperature and/or humidity should be avoided.

Rx only

US30 Rev. 4-07

Manufactured for:
Graceway Pharmaceuticals, LLC
Bristol, TN 37620

by:
3M Drug Delivery Systems
Northridge, CA 91324

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 29336-321-30
Nitroglycerin
Transdermal Delivery System
0.1 mg/hr
Contents: 1 System
Each 3.3 cm2 sytem contains 9 mg of nitroglycerin.
Rated release in vivo, 0.1 mg/hr.
Rx Only
Manufactured for:
Graceway Pharmaceuticals, LLC, Bristol, TN 37620
by: 3M Drug Delivery Systems, Northridge, CA 91324438200 US23 Rev0407

0.1 mg/hr label image
(click image for full-size original)

NDC 29336-322-30
Nitroglycerin
Transdermal Delivery System
0.2 mg/hr
Contents: 1 System
Each 6.7 cm2 sytem contains 18 mg of nitroglycerin.
Rated release in vivo, 0.2 mg/hr.
Rx Only
Manufactured for:
Graceway Pharmaceuticals, LLC, Bristol, TN 37620
by: 3M Drug Delivery Systems, Northridge, CA 91324438300 US24 Rev0407

0.2 mg/hr label image
(click image for full-size original)

NDC 29336-323-30
Nitroglycerin
Transdermal Delivery System
0.4 mg/hr
Contents: 1 System
Each 13.3 cm2 sytem contains 36 mg of nitroglycerin.
Rated release in vivo, 0.4 mg/hr.
Rx Only
Manufactured for:
Graceway Pharmaceuticals, LLC, Bristol, TN 37620
by: 3M Drug Delivery Systems, Northridge, CA 91324438400 US26 Rev0407

0.4 mg/hr label image
(click image for full-size original)

NDC 29336-324-30
Nitroglycerin
Transdermal Delivery System
0.6 mg/hr
Contents: 1 System
Each 20 cm2 sytem contains 54 mg of nitroglycerin.
Rated release in vivo, 0.6 mg/hr.
Rx Only
Manufactured for:
Graceway Pharmaceuticals, LLC, Bristol, TN 37620
by: 3M Drug Delivery Systems, Northridge, CA 91324438600 US27 Rev0407

0.6 mg/hr label image
(click image for full-size original)
NITROGLYCERIN TRANSDERMAL DELIVERY SYSTEM nitroglycerin patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29336-321
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
nitroglycerin (nitroglycerin) nitroglycerin 2.5 mg in 1 d
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29336-321-30 30 PATCH (PATCH) in 1 CARTON contains a PATCH
1 1 d in 1 PATCH This package is contained within the CARTON (29336-321-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089771 04/01/2007
NITROGLYCERIN TRANSDERMAL DELIVERY SYSTEM nitroglycerin patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29336-322
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
nitroglycerin (nitroglycerin) nitroglycerin 5 mg in 1 d
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29336-322-30 30 PATCH (PATCH) in 1 CARTON contains a PATCH
1 1 d in 1 PATCH This package is contained within the CARTON (29336-322-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089772 04/01/2007
NITROGLYCERIN TRANSDERMAL DELIVERY SYSTEM nitroglycerin patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29336-323
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
nitroglycerin (nitroglycerin) nitroglycerin 10 mg in 1 d
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29336-323-30 30 PATCH (PATCH) in 1 CARTON contains a PATCH
1 1 d in 1 PATCH This package is contained within the CARTON (29336-323-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089773 04/04/2007
NITROGLYCERIN TRANSDERMAL DELIVERY SYSTEM nitroglycerin patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29336-324
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
nitroglycerin (nitroglycerin) nitroglycerin 15 mg in 1 d
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29336-324-30 30 PATCH (PATCH) in 1 CARTON contains a PATCH
1 1 d in 1 PATCH This package is contained within the CARTON (29336-324-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089774 04/01/2007
Labeler — Graceway Pharmaceuticals, LLC (613448161)
Registrant — Graceway Pharmaceuticals, LLC (613448161)
Establishment
Name Address ID/FEI Operations
3M Drug Delivery Systems 128688199 MANUFACTURE

Revised: 11/2009 Graceway Pharmaceuticals, LLC

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