FDA.reportPublic FDA data

Nitrostat

Product NDC
58151-311
11-digit product format
581510311
Labeler code
58151
Product ID
58151-311_793962da-82d4-4fe1-b78d-dccf10a8ff85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitroglycerin
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Viatris Specialty LLC
Application
NDA021134
Marketing category
NDA
Marketing start
2024-02-09
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
Nitrostat
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, 207331, 207346, 207361

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
58151-311-01Nitrostat100 in 1 BOTTLETABLET1003
58151-311-01Nitrostat1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-311NITROSTAT (NITROGLYCERIN) TABLET [VIATRIS SPECIALTY LLC]3Current NDC, 2 package rows20240606_9a52da75-d0af-4237-96c0-0b12adfa8636.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198038nitroglycerin 0.3 MG Sublingual TabletPSN9a52da75-d0af-4237-96c0-0b12adfa86363
198039nitroglycerin 0.4 MG Sublingual TabletPSN9a52da75-d0af-4237-96c0-0b12adfa86363
198040nitroglycerin 0.6 MG Sublingual TabletPSN9a52da75-d0af-4237-96c0-0b12adfa86363
207331Nitrostat 0.3 MG Sublingual TabletPSN9a52da75-d0af-4237-96c0-0b12adfa86363
207346Nitrostat 0.4 MG Sublingual TabletPSN9a52da75-d0af-4237-96c0-0b12adfa86363
207361Nitrostat 0.6 MG Sublingual TabletPSN9a52da75-d0af-4237-96c0-0b12adfa86363
207331nitroglycerin 0.3 MG Sublingual Tablet [Nitrostat]SBD9a52da75-d0af-4237-96c0-0b12adfa86363
207346nitroglycerin 0.4 MG Sublingual Tablet [Nitrostat]SBD9a52da75-d0af-4237-96c0-0b12adfa86363
207361nitroglycerin 0.6 MG Sublingual Tablet [Nitrostat]SBD9a52da75-d0af-4237-96c0-0b12adfa86363
198038nitroglycerin 0.3 MG Sublingual TabletSCD9a52da75-d0af-4237-96c0-0b12adfa86363
198039nitroglycerin 0.4 MG Sublingual TabletSCD9a52da75-d0af-4237-96c0-0b12adfa86363
198040nitroglycerin 0.6 MG Sublingual TabletSCD9a52da75-d0af-4237-96c0-0b12adfa86363
198038nitroglycerin 300 MCG Sublingual TabletSY9a52da75-d0af-4237-96c0-0b12adfa86363
198039nitroglycerin 400 MCG Sublingual TabletSY9a52da75-d0af-4237-96c0-0b12adfa86363
198040nitroglycerin 600 MCG Sublingual TabletSY9a52da75-d0af-4237-96c0-0b12adfa86363
207331Nitrostat 0.3 MG Sublingual TabletSY9a52da75-d0af-4237-96c0-0b12adfa86363
207346Nitrostat 0.4 MG Sublingual TabletSY9a52da75-d0af-4237-96c0-0b12adfa86363
207361Nitrostat 0.6 MG Sublingual TabletSY9a52da75-d0af-4237-96c0-0b12adfa86363
198038NTG 0.3 MG Sublingual TabletSY9a52da75-d0af-4237-96c0-0b12adfa86363
207331NTG 0.3 MG Sublingual Tablet [Nitrostat]SY9a52da75-d0af-4237-96c0-0b12adfa86363
198039NTG 0.4 MG Sublingual TabletSY9a52da75-d0af-4237-96c0-0b12adfa86363
207346NTG 0.4 MG Sublingual Tablet [Nitrostat]SY9a52da75-d0af-4237-96c0-0b12adfa86363
198040NTG 0.6 MG Sublingual TabletSY9a52da75-d0af-4237-96c0-0b12adfa86363
207361NTG 0.6 MG Sublingual Tablet [Nitrostat]SY9a52da75-d0af-4237-96c0-0b12adfa86363
198038TNG 0.3 MG Sublingual TabletSY9a52da75-d0af-4237-96c0-0b12adfa86363
207331TNG 0.3 MG Sublingual Tablet [Nitrostat]SY9a52da75-d0af-4237-96c0-0b12adfa86363
198039TNG 0.4 MG Sublingual TabletSY9a52da75-d0af-4237-96c0-0b12adfa86363
207346TNG 0.4 MG Sublingual Tablet [Nitrostat]SY9a52da75-d0af-4237-96c0-0b12adfa86363
198040TNG 0.6 MG Sublingual TabletSY9a52da75-d0af-4237-96c0-0b12adfa86363
207361TNG 0.6 MG Sublingual Tablet [Nitrostat]SY9a52da75-d0af-4237-96c0-0b12adfa86363

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58151-311-01581510311011 BOTTLE in 1 CARTON (58151-311-01) / 100 TABLET in 1 BOTTLE1 bottle2024-02-09NoNoCurrent