FDA.reportPublic FDA data

Nitrostat

Product NDC
58151-310
11-digit product format
581510310
Labeler code
58151
Product ID
58151-310_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
2024-02-02
Substance
NITROGLYCERIN
Active strength
.4 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.4 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
58151-310-01Nitrostat1 in 1 CARTONTABLET13
58151-310-01Nitrostat100 in 1 BOTTLETABLET1003
58151-310-52Nitrostat4 in 1 CARTONTABLET43
58151-310-94Nitrostat25 in 1 BOTTLETABLET253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-310NITROSTAT (NITROGLYCERIN) TABLET [VIATRIS SPECIALTY LLC]3Current NDC, 4 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 TabletPSNf7059ff7-bf74-48b4-811d-6eb1c26bfd8b3
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
207346Nitrostat 0.4 MG Sublingual TabletPSNf7059ff7-bf74-48b4-811d-6eb1c26bfd8b3
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
207346nitroglycerin 0.4 MG Sublingual Tablet [Nitrostat]SBDf7059ff7-bf74-48b4-811d-6eb1c26bfd8b3
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 TabletSCDf7059ff7-bf74-48b4-811d-6eb1c26bfd8b3
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
198039nitroglycerin 400 MCG Sublingual TabletSYf7059ff7-bf74-48b4-811d-6eb1c26bfd8b3
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
207346Nitrostat 0.4 MG Sublingual TabletSYf7059ff7-bf74-48b4-811d-6eb1c26bfd8b3
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
198039NTG 0.4 MG Sublingual TabletSYf7059ff7-bf74-48b4-811d-6eb1c26bfd8b3
207346NTG 0.4 MG Sublingual Tablet [Nitrostat]SY9a52da75-d0af-4237-96c0-0b12adfa86363
207346NTG 0.4 MG Sublingual Tablet [Nitrostat]SYf7059ff7-bf74-48b4-811d-6eb1c26bfd8b3
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
198039TNG 0.4 MG Sublingual TabletSYf7059ff7-bf74-48b4-811d-6eb1c26bfd8b3
207346TNG 0.4 MG Sublingual Tablet [Nitrostat]SYf7059ff7-bf74-48b4-811d-6eb1c26bfd8b3
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
198039nitroglycerin 0.4 MG Sublingual TabletPSN5265648f-3062-48a2-a4e3-fea1207807a82
207346Nitrostat 0.4 MG Sublingual TabletPSN5265648f-3062-48a2-a4e3-fea1207807a82
207346nitroglycerin 0.4 MG Sublingual Tablet [Nitrostat]SBD5265648f-3062-48a2-a4e3-fea1207807a82
198039nitroglycerin 0.4 MG Sublingual TabletSCD5265648f-3062-48a2-a4e3-fea1207807a82
198039nitroglycerin 400 MCG Sublingual TabletSY5265648f-3062-48a2-a4e3-fea1207807a82
207346Nitrostat 0.4 MG Sublingual TabletSY5265648f-3062-48a2-a4e3-fea1207807a82
198039NTG 0.4 MG Sublingual TabletSY5265648f-3062-48a2-a4e3-fea1207807a82
207346NTG 0.4 MG Sublingual Tablet [Nitrostat]SY5265648f-3062-48a2-a4e3-fea1207807a82
198039TNG 0.4 MG Sublingual TabletSY5265648f-3062-48a2-a4e3-fea1207807a82
207346TNG 0.4 MG Sublingual Tablet [Nitrostat]SY5265648f-3062-48a2-a4e3-fea1207807a82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58151-310-01581510310011 BOTTLE in 1 CARTON (58151-310-01) / 100 TABLET in 1 BOTTLE1 bottle2024-02-02NoNoCurrent
58151-310-52581510310524 BOTTLE in 1 CARTON (58151-310-52) / 25 TABLET in 1 BOTTLE (58151-310-94) 4 bottle2024-02-02NoNoCurrent
58151-310-945815103109425 in 1 BOTTLEHistorical