FDA.reportPublic FDA data

Nitrostat

Product NDC
53217-066
11-digit product format
532170066
Labeler code
53217
Product ID
53217-066_1ffe0c86-333f-4852-9051-3c98411e494d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitroglycerin
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Aidarex Pharmaceuticals LLC
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
No
Listing certified through
2019-12-31
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
53217-066-002020-01-31C16284748780-19d75b9cf-f206-f424-e053-dadaa90a57ceNitrostat ® (Nitroglycerin Sublingual Tablets, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-066-00Nitrostat1 in 1 CARTONTABLET11
53217-066-00Nitrostat100 in 1 BOTTLE, PLASTICTABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-066-00EA - Each53217-066780acfee-6651-4ad3-a477-9b2e53cd909e12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROGLYCERINACTIVE INGREDIENTG59M7S0WS3NITROSTAT (NITROGLYCERIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
NITROGLYCERINACTIVE MOIETYG59M7S0WS3NITROSTAT (NITROGLYCERIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LNITROSTAT (NITROGLYCERIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4NITROSTAT (NITROGLYCERIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNITROSTAT (NITROGLYCERIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NITROSTAT (NITROGLYCERIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNITROSTAT (NITROGLYCERIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-066NITROSTAT (NITROGLYCERIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20140214_3d426e54-489b-4ef7-be06-16762877ce74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198039nitroglycerin 0.4 MG Sublingual TabletPSN3d426e54-489b-4ef7-be06-16762877ce741
207346Nitrostat 0.4 MG Sublingual TabletPSN3d426e54-489b-4ef7-be06-16762877ce741
207346nitroglycerin 0.4 MG Sublingual Tablet [Nitrostat]SBD3d426e54-489b-4ef7-be06-16762877ce741
198039nitroglycerin 0.4 MG Sublingual TabletSCD3d426e54-489b-4ef7-be06-16762877ce741
198039nitroglycerin 400 MCG Sublingual TabletSY3d426e54-489b-4ef7-be06-16762877ce741
207346Nitrostat 0.4 MG Sublingual TabletSY3d426e54-489b-4ef7-be06-16762877ce741
198039NTG 0.4 MG Sublingual TabletSY3d426e54-489b-4ef7-be06-16762877ce741
207346NTG 0.4 MG Sublingual Tablet [Nitrostat]SY3d426e54-489b-4ef7-be06-16762877ce741
198039TNG 0.4 MG Sublingual TabletSY3d426e54-489b-4ef7-be06-16762877ce741
207346TNG 0.4 MG Sublingual Tablet [Nitrostat]SY3d426e54-489b-4ef7-be06-16762877ce741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-066-00532170066001 in 1 CARTONHistorical