FDA.reportPublic FDA data

Nitroglycerin Transdermal Delivery System

Product NDC
29336-324
11-digit product format
293360324
Labeler code
29336
Product ID
29336-324_590f4d2a-cb56-0b3e-4301-7bf5c148e3a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitroglycerin
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Graceway Pharmaceuticals, LLC
Application
ANDA089774
Marketing category
ANDA
Marketing start
2007-04-01
Marketing end
0000-00-00
Substance
NITROGLYCERIN
Active strength
15 mg/d
Pharmacologic classes
Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
29336-324-302019-10-21C16284748780-1956f9ecf-ce37-621f-e053-dbdaa90a74adfcd4cf8a-e3e6-7da9-6355-c60b7400291a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29336-324-30Nitroglycerin Transdermal Delivery System1 d in 1 PATCHPATCH13
29336-324-30Nitroglycerin Transdermal Delivery System30 in 1 CARTONPATCH303

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
nitroglycerinACTIVE INGREDIENTG59M7S0WS3NITROGLYCERIN TRANSDERMAL DELIVERY SYSTEM (NITROGLYCERIN) PATCH [GRACEWAY PHARMACEUTICALS, LLC]3
nitroglycerinACTIVE MOIETYG59M7S0WS3NITROGLYCERIN TRANSDERMAL DELIVERY SYSTEM (NITROGLYCERIN) PATCH [GRACEWAY PHARMACEUTICALS, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29336-324NITROGLYCERIN TRANSDERMAL DELIVERY SYSTEM (NITROGLYCERIN) PATCH [GRACEWAY PHARMACEUTICALS, LLC]3Legacy NDC, 2 package rows20091215_fcd4cf8a-e3e6-7da9-6355-c60b7400291a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861657nitroglycerin 0.1 MG/HR 24HR Transdermal SystemPSNfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
486148nitroglycerin 0.2 MG/HR 24HR Transdermal SystemPSNfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
486152nitroglycerin 0.4 MG/HR 24HR Transdermal SystemPSNfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
486146nitroglycerin 0.6 MG/HR 24HR Transdermal SystemPSNfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
86165724 HR nitroglycerin 0.1 MG/HR Transdermal SystemSCDfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
48614824 HR nitroglycerin 0.2 MG/HR Transdermal SystemSCDfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
48615224 HR nitroglycerin 0.4 MG/HR Transdermal SystemSCDfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
48614624 HR nitroglycerin 0.6 MG/HR Transdermal SystemSCDfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
86165724 HR NTG 0.1 MG/HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
48614824 HR NTG 0.2 MG/HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
48615224 HR NTG 0.4 MG/HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
48614624 HR NTG 0.6 MG/HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
86165724 HR TNG 0.1 MG/HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
48614824 HR TNG 0.2 MG/HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
48615224 HR TNG 0.4 MG/HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
48614624 HR TNG 0.6 MG/HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
861657nitroglycerin 0.1 MG/HR 24 HR Transdermal PatchSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
861657nitroglycerin 0.1 MG/HR 24HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
486148nitroglycerin 0.2 MG/HR 24HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
486152nitroglycerin 0.4 MG/HR 24HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
486146nitroglycerin 0.6 MG/HR 24HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
486152nitroglycerin 10 MG/Day 24 HR Transdermal PatchSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
486146nitroglycerin 14 MG/Day 24 HR Transdermal PatchSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
486148nitroglycerin 5 MG/Day 24 HR Transdermal PatchSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
29336-324-30293360324301 d in 1 PATCH1 dHistorical