FDA.reportPublic FDA data

NITRO-DUR

Product NDC
50742-513
11-digit product format
507420513
Labeler code
50742
Product ID
50742-513_fcec90fc-83c9-15e2-e053-6394a90ab2d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitroglycerin
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
NDA020145
Marketing category
NDA
Marketing start
2017-12-06
Substance
NITROGLYCERIN
Active strength
20 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NITRO-DUR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGLYCERIN20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG59M7S0WS3
Rxcui486146, 486148, 486152, 861657, 899521, 899607, 899642, 899660, 899688, 899690, 899703, 899705

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50742-513-30NITRO-DUR30 in 1 BOX, UNIT-DOSEPATCH306
50742-513-30NITRO-DUR1 in 1 POUCHPATCH16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-513-30EA - Each50742-5137f39ad31-1d6f-4362-8b3e-141c29cf4dfa12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-513NITRO-DUR (NITROGLYCERIN) PATCH [INGENUS PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 2 package rows20230531_5e15296c-5acd-4bcc-80a8-b49cb1ef3eb0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
899660Nitro-Dur 0.1 MG/HR 24HR Transdermal SystemPSN5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
899521Nitro-Dur 0.2 MG/HR 24HR Transdermal SystemPSN5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
899690Nitro-Dur 0.3 MG/HR 24HR Transdermal SystemPSN5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
899607Nitro-Dur 0.4 MG/HR 24HR Transdermal SystemPSN5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
899642Nitro-Dur 0.6 MG/HR 24HR Transdermal SystemPSN5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
899705Nitro-Dur 0.8 MG/HR 24HR Transdermal SystemPSN5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
861657nitroglycerin 0.1 MG/HR 24HR Transdermal SystemPSN5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
486148nitroglycerin 0.2 MG/HR 24HR Transdermal SystemPSN5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
899688nitroglycerin 0.3 MG/HR 24HR Transdermal SystemPSN5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
486152nitroglycerin 0.4 MG/HR 24HR Transdermal SystemPSN5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
486146nitroglycerin 0.6 MG/HR 24HR Transdermal SystemPSN5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
899703nitroglycerin 0.8 MG/HR 24HR Transdermal SystemPSN5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89966024 HR nitroglycerin 0.1 MG/HR Transdermal System [Nitro-Dur]SBD5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89952124 HR nitroglycerin 0.2 MG/HR Transdermal System [Nitro-Dur]SBD5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89969024 HR nitroglycerin 0.3 MG/HR Transdermal System [Nitro-Dur]SBD5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89960724 HR nitroglycerin 0.4 MG/HR Transdermal System [Nitro-Dur]SBD5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89964224 HR nitroglycerin 0.6 MG/HR Transdermal System [Nitro-Dur]SBD5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89970524 HR nitroglycerin 0.8 MG/HR Transdermal System [Nitro-Dur]SBD5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
86165724 HR nitroglycerin 0.1 MG/HR Transdermal SystemSCD5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
48614824 HR nitroglycerin 0.2 MG/HR Transdermal SystemSCD5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89968824 HR nitroglycerin 0.3 MG/HR Transdermal SystemSCD5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
48615224 HR nitroglycerin 0.4 MG/HR Transdermal SystemSCD5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
48614624 HR nitroglycerin 0.6 MG/HR Transdermal SystemSCD5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89970324 HR nitroglycerin 0.8 MG/HR Transdermal SystemSCD5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89966024 HR Nitro-Dur 0.1 MG/HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89952124 HR Nitro-Dur 0.2 MG/HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89969024 HR Nitro-Dur 0.3 MG/HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89960724 HR Nitro-Dur 0.4 MG/HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89964224 HR Nitro-Dur 0.6 MG/HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89970524 HR Nitro-Dur 0.8 MG/HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
86165724 HR NTG 0.1 MG/HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89966024 HR NTG 0.1 MG/HR Transdermal System [Nitro-Dur]SY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
48614824 HR NTG 0.2 MG/HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89952124 HR NTG 0.2 MG/HR Transdermal System [Nitro-Dur]SY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89968824 HR NTG 0.3 MG/HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89969024 HR NTG 0.3 MG/HR Transdermal System [Nitro-Dur]SY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
48615224 HR NTG 0.4 MG/HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89960724 HR NTG 0.4 MG/HR Transdermal System [Nitro-Dur]SY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
48614624 HR NTG 0.6 MG/HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89964224 HR NTG 0.6 MG/HR Transdermal System [Nitro-Dur]SY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89970324 HR NTG 0.8 MG/HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89970524 HR NTG 0.8 MG/HR Transdermal System [Nitro-Dur]SY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
86165724 HR TNG 0.1 MG/HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89966024 HR TNG 0.1 MG/HR Transdermal System [Nitro-Dur]SY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
48614824 HR TNG 0.2 MG/HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89952124 HR TNG 0.2 MG/HR Transdermal System [Nitro-Dur]SY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89968824 HR TNG 0.3 MG/HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89969024 HR TNG 0.3 MG/HR Transdermal System [Nitro-Dur]SY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
48615224 HR TNG 0.4 MG/HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89960724 HR TNG 0.4 MG/HR Transdermal System [Nitro-Dur]SY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
48614624 HR TNG 0.6 MG/HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89964224 HR TNG 0.6 MG/HR Transdermal System [Nitro-Dur]SY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89970324 HR TNG 0.8 MG/HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
89970524 HR TNG 0.8 MG/HR Transdermal System [Nitro-Dur]SY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
899660Nitro-Dur 0.1 MG/HR 24HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
899521Nitro-Dur 0.2 MG/HR 24HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
899690Nitro-Dur 0.3 MG/HR 24HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
899607Nitro-Dur 0.4 MG/HR 24HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
899642Nitro-Dur 0.6 MG/HR 24HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
899705Nitro-Dur 0.8 MG/HR 24HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
899607Nitro-Dur 10 MG per 24HR Daily Transdermal PatchSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
899642Nitro-Dur 15 MG per 24HR Daily Transdermal PatchSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
899660Nitro-Dur 2.5 MG per 24HR Daily Transdermal PatchSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
899705Nitro-Dur 20 MG per 24HR Daily Transdermal PatchSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
899521Nitro-Dur 5 MG per 24HR Daily Transdermal PatchSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
899690Nitro-Dur 7.5 MG per 24HR Daily Transdermal PatchSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
861657nitroglycerin 0.1 MG/HR 24 HR Transdermal PatchSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
861657nitroglycerin 0.1 MG/HR 24HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
486148nitroglycerin 0.2 MG/HR 24HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
899688nitroglycerin 0.3 MG/HR 24 HR Transdermal PatchSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
899688nitroglycerin 0.3 MG/HR 24HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
486152nitroglycerin 0.4 MG/HR 24HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
486146nitroglycerin 0.6 MG/HR 24HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
899703nitroglycerin 0.8 MG/HR 24 HR Transdermal PatchSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
899703nitroglycerin 0.8 MG/HR 24HR Transdermal SystemSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
486152nitroglycerin 10 MG/Day 24 HR Transdermal PatchSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
486146nitroglycerin 14 MG/Day 24 HR Transdermal PatchSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06
486148nitroglycerin 5 MG/Day 24 HR Transdermal PatchSY5e15296c-5acd-4bcc-80a8-b49cb1ef3eb06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50742-513-305074205133030 POUCH in 1 BOX, UNIT-DOSE (50742-513-30) / 1 PATCH in 1 POUCH30 pouch2017-12-060000-00-00NoNoCurrent