FDA.reportPublic FDA data

NITROGLYCERIN

Product NDC
59762-0489
11-digit product format
597620489
Labeler code
59762
Product ID
59762-0489_2ac009f2-257f-4603-a1e8-c50aa9e31f4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitroglycerin
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA021134
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-08-26
Substance
NITROGLYCERIN
Active strength
.6 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGLYCERIN.6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG59M7S0WS3
Rxcui198038, 198039, 198040

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
59762-0489-1NITROGLYCERIN1 in 1 CARTONTABLET115
59762-0489-1NITROGLYCERIN100 in 1 BOTTLE, GLASSTABLET10015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0489NITROGLYCERIN TABLET [MYLAN PHARMACEUTICALS INC.]15Current NDC, Legacy NDC, 2 package rows20250503_041f127e-5166-4484-bc1a-0a373d1187ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198038nitroglycerin 0.3 MG Sublingual TabletPSN041f127e-5166-4484-bc1a-0a373d1187ae15
198039nitroglycerin 0.4 MG Sublingual TabletPSN041f127e-5166-4484-bc1a-0a373d1187ae15
198040nitroglycerin 0.6 MG Sublingual TabletPSN041f127e-5166-4484-bc1a-0a373d1187ae15
198038nitroglycerin 0.3 MG Sublingual TabletSCD041f127e-5166-4484-bc1a-0a373d1187ae15
198039nitroglycerin 0.4 MG Sublingual TabletSCD041f127e-5166-4484-bc1a-0a373d1187ae15
198040nitroglycerin 0.6 MG Sublingual TabletSCD041f127e-5166-4484-bc1a-0a373d1187ae15
198038nitroglycerin 300 MCG Sublingual TabletSY041f127e-5166-4484-bc1a-0a373d1187ae15
198039nitroglycerin 400 MCG Sublingual TabletSY041f127e-5166-4484-bc1a-0a373d1187ae15
198040nitroglycerin 600 MCG Sublingual TabletSY041f127e-5166-4484-bc1a-0a373d1187ae15
198038NTG 0.3 MG Sublingual TabletSY041f127e-5166-4484-bc1a-0a373d1187ae15
198039NTG 0.4 MG Sublingual TabletSY041f127e-5166-4484-bc1a-0a373d1187ae15
198040NTG 0.6 MG Sublingual TabletSY041f127e-5166-4484-bc1a-0a373d1187ae15
198038TNG 0.3 MG Sublingual TabletSY041f127e-5166-4484-bc1a-0a373d1187ae15
198039TNG 0.4 MG Sublingual TabletSY041f127e-5166-4484-bc1a-0a373d1187ae15
198040TNG 0.6 MG Sublingual TabletSY041f127e-5166-4484-bc1a-0a373d1187ae15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-0489-1597620489011 BOTTLE, GLASS in 1 CARTON (59762-0489-1) / 100 TABLET in 1 BOTTLE, GLASS2016-08-260000-00-00NoNoCurrent