FDA.reportPublic FDA data

Nitroglycerin Transdermal Infusion System

Product NDC
43598-895
11-digit product format
435980895
Labeler code
43598
Product ID
43598-895_10b34299-d60a-f785-70d6-2e5cc344638c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitroglycerin
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Dr. Reddy's Laboratories, Inc.
Application
NDA020145
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-03-01
Substance
NITROGLYCERIN
Active strength
40 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
Nitroglycerin Transdermal Infusion System
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGLYCERIN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG59M7S0WS3
Rxcui486146, 486148, 486152, 861657

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
43598-895-30Nitroglycerin Transdermal Infusion System1 in 1 POUCHPATCH12
43598-895-30Nitroglycerin Transdermal Infusion System30 in 1 BOX, UNIT-DOSEPATCH302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-895NITROGLYCERIN TRANSDERMAL INFUSION SYSTEM (NITROGLYCERIN) PATCH [DR. REDDY'S LABORATORIES, INC.]2Current NDC, Legacy NDC, 2 package rows20200414_4f85d2e0-2e37-fcd1-276d-5a6466554289.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861657nitroglycerin 0.1 MG/HR 24HR Transdermal SystemPSN4f85d2e0-2e37-fcd1-276d-5a64665542892
486148nitroglycerin 0.2 MG/HR 24HR Transdermal SystemPSN4f85d2e0-2e37-fcd1-276d-5a64665542892
486152nitroglycerin 0.4 MG/HR 24HR Transdermal SystemPSN4f85d2e0-2e37-fcd1-276d-5a64665542892
486146nitroglycerin 0.6 MG/HR 24HR Transdermal SystemPSN4f85d2e0-2e37-fcd1-276d-5a64665542892
86165724 HR nitroglycerin 0.1 MG/HR Transdermal SystemSCD4f85d2e0-2e37-fcd1-276d-5a64665542892
48614824 HR nitroglycerin 0.2 MG/HR Transdermal SystemSCD4f85d2e0-2e37-fcd1-276d-5a64665542892
48615224 HR nitroglycerin 0.4 MG/HR Transdermal SystemSCD4f85d2e0-2e37-fcd1-276d-5a64665542892
48614624 HR nitroglycerin 0.6 MG/HR Transdermal SystemSCD4f85d2e0-2e37-fcd1-276d-5a64665542892
86165724 HR NTG 0.1 MG/HR Transdermal SystemSY4f85d2e0-2e37-fcd1-276d-5a64665542892
48614824 HR NTG 0.2 MG/HR Transdermal SystemSY4f85d2e0-2e37-fcd1-276d-5a64665542892
48615224 HR NTG 0.4 MG/HR Transdermal SystemSY4f85d2e0-2e37-fcd1-276d-5a64665542892
48614624 HR NTG 0.6 MG/HR Transdermal SystemSY4f85d2e0-2e37-fcd1-276d-5a64665542892
86165724 HR TNG 0.1 MG/HR Transdermal SystemSY4f85d2e0-2e37-fcd1-276d-5a64665542892
48614824 HR TNG 0.2 MG/HR Transdermal SystemSY4f85d2e0-2e37-fcd1-276d-5a64665542892
48615224 HR TNG 0.4 MG/HR Transdermal SystemSY4f85d2e0-2e37-fcd1-276d-5a64665542892
48614624 HR TNG 0.6 MG/HR Transdermal SystemSY4f85d2e0-2e37-fcd1-276d-5a64665542892
861657nitroglycerin 0.1 MG/HR 24 HR Transdermal PatchSY4f85d2e0-2e37-fcd1-276d-5a64665542892
861657nitroglycerin 0.1 MG/HR 24HR Transdermal SystemSY4f85d2e0-2e37-fcd1-276d-5a64665542892
486148nitroglycerin 0.2 MG/HR 24HR Transdermal SystemSY4f85d2e0-2e37-fcd1-276d-5a64665542892
486152nitroglycerin 0.4 MG/HR 24HR Transdermal SystemSY4f85d2e0-2e37-fcd1-276d-5a64665542892
486146nitroglycerin 0.6 MG/HR 24HR Transdermal SystemSY4f85d2e0-2e37-fcd1-276d-5a64665542892
486152nitroglycerin 10 MG/Day 24 HR Transdermal PatchSY4f85d2e0-2e37-fcd1-276d-5a64665542892
486146nitroglycerin 14 MG/Day 24 HR Transdermal PatchSY4f85d2e0-2e37-fcd1-276d-5a64665542892
486148nitroglycerin 5 MG/Day 24 HR Transdermal PatchSY4f85d2e0-2e37-fcd1-276d-5a64665542892

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-895-304359808953030 POUCH in 1 BOX, UNIT-DOSE (43598-895-30) / 1 PATCH in 1 POUCH30 pouch2020-03-010000-00-00NoNoCurrent