FDA.reportPublic FDA data

Nitrostat

Product NDC
21695-450
11-digit product format
216950450
Labeler code
21695
Product ID
21695-450_dcb552c1-310a-48af-81ad-a74530531dee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitroglycerin
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Rebel Distributors Corp
Application
NDA021134
Marketing category
NDA
Marketing start
2000-05-01
Marketing end
0000-00-00
Substance
NITROGLYCERIN
Active strength
0 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-450-002019-09-24C16284748780-1934fe258-47d6-48b1-e053-8cdaa90a720aNitrostat ® (Nitroglycerin Sublingual Tablets, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-450-00Nitrostat100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-450-00EA - Each21695-4507a547b3a-abbc-435d-9967-2531d088ae1312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
nitroglycerinACTIVE INGREDIENTG59M7S0WS3NITROSTAT (NITROGLYCERIN) TABLET [REBEL DISTRIBUTORS CORP]1
nitroglycerinACTIVE MOIETYG59M7S0WS3NITROSTAT (NITROGLYCERIN) TABLET [REBEL DISTRIBUTORS CORP]1
calcium stearateINACTIVE INGREDIENT776XM7047LNITROSTAT (NITROGLYCERIN) TABLET [REBEL DISTRIBUTORS CORP]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4NITROSTAT (NITROGLYCERIN) TABLET [REBEL DISTRIBUTORS CORP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XNITROSTAT (NITROGLYCERIN) TABLET [REBEL DISTRIBUTORS CORP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4NITROSTAT (NITROGLYCERIN) TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-450NITROSTAT (NITROGLYCERIN) TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20120420_dcb552c1-310a-48af-81ad-a74530531dee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198039nitroglycerin 0.4 MG Sublingual TabletPSNdcb552c1-310a-48af-81ad-a74530531dee1
207346Nitrostat 0.4 MG Sublingual TabletPSNdcb552c1-310a-48af-81ad-a74530531dee1
207346nitroglycerin 0.4 MG Sublingual Tablet [Nitrostat]SBDdcb552c1-310a-48af-81ad-a74530531dee1
198039nitroglycerin 0.4 MG Sublingual TabletSCDdcb552c1-310a-48af-81ad-a74530531dee1
198039nitroglycerin 400 MCG Sublingual TabletSYdcb552c1-310a-48af-81ad-a74530531dee1
207346Nitrostat 0.4 MG Sublingual TabletSYdcb552c1-310a-48af-81ad-a74530531dee1
198039NTG 0.4 MG Sublingual TabletSYdcb552c1-310a-48af-81ad-a74530531dee1
207346NTG 0.4 MG Sublingual Tablet [Nitrostat]SYdcb552c1-310a-48af-81ad-a74530531dee1
198039TNG 0.4 MG Sublingual TabletSYdcb552c1-310a-48af-81ad-a74530531dee1
207346TNG 0.4 MG Sublingual Tablet [Nitrostat]SYdcb552c1-310a-48af-81ad-a74530531dee1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-450-0021695045000100 in 1 BOTTLEHistorical