FDA.reportPublic FDA data

Nitrostat

Product NDC
0071-0418
11-digit product format
000710418
Labeler code
0071
Product ID
0071-0418_b21bdc0d-86ca-4a5f-9695-a7a8064f5bed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitroglycerin
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Parke-Davis Div of Pfizer Inc
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
2020-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0071-0418-13EA - Each0071-0418d6b5ab77-bb5e-4885-85d9-23c0ea17452312012-07-24
0071-0418-24EA - Each0071-04183dfdfaa5-a4f3-41c0-9cd8-34e8137c374e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROGLYCERINACTIVE INGREDIENTG59M7S0WS3NITROSTAT (NITROGLYCERIN) TABLET [PARKE-DAVIS DIV OF PFIZER INC]8
NITROGLYCERINACTIVE MOIETYG59M7S0WS3NITROSTAT (NITROGLYCERIN) TABLET [PARKE-DAVIS DIV OF PFIZER INC]8
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LNITROSTAT (NITROGLYCERIN) TABLET [PARKE-DAVIS DIV OF PFIZER INC]8
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4NITROSTAT (NITROGLYCERIN) TABLET [PARKE-DAVIS DIV OF PFIZER INC]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNITROSTAT (NITROGLYCERIN) TABLET [PARKE-DAVIS DIV OF PFIZER INC]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NITROSTAT (NITROGLYCERIN) TABLET [PARKE-DAVIS DIV OF PFIZER INC]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNITROSTAT (NITROGLYCERIN) TABLET [PARKE-DAVIS DIV OF PFIZER INC]8
NITROGLYCERINACTIVE INGREDIENTG59M7S0WS3NITROSTAT (NITROGLYCERIN) TABLET [PHYSICIANS TOTAL CARE, INC.]1
NITROGLYCERINACTIVE INGREDIENTG59M7S0WS3NITROSTAT (NITROGLYCERIN) TABLET [A-S MEDICATION SOLUTIONS LLC]1
NITROGLYCERINACTIVE INGREDIENTG59M7S0WS3NITROSTAT (NITROGLYCERIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
nitroglycerinACTIVE INGREDIENTG59M7S0WS3NITROSTAT (NITROGLYCERIN) TABLET [REBEL DISTRIBUTORS CORP]1
nitroglycerinACTIVE MOIETYG59M7S0WS3NITROSTAT (NITROGLYCERIN) TABLET [REBEL DISTRIBUTORS CORP]1
NITROGLYCERINACTIVE MOIETYG59M7S0WS3NITROSTAT (NITROGLYCERIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
NITROGLYCERINACTIVE MOIETYG59M7S0WS3NITROSTAT (NITROGLYCERIN) TABLET [A-S MEDICATION SOLUTIONS LLC]1
NITROGLYCERINACTIVE MOIETYG59M7S0WS3NITROSTAT (NITROGLYCERIN) TABLET [PHYSICIANS TOTAL CARE, INC.]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LNITROSTAT (NITROGLYCERIN) TABLET [A-S MEDICATION SOLUTIONS LLC]1
calcium stearateINACTIVE INGREDIENT776XM7047LNITROSTAT (NITROGLYCERIN) TABLET [REBEL DISTRIBUTORS CORP]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LNITROSTAT (NITROGLYCERIN) TABLET [PHYSICIANS TOTAL CARE, INC.]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LNITROSTAT (NITROGLYCERIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4NITROSTAT (NITROGLYCERIN) TABLET [PHYSICIANS TOTAL CARE, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4NITROSTAT (NITROGLYCERIN) TABLET [A-S MEDICATION SOLUTIONS LLC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4NITROSTAT (NITROGLYCERIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4NITROSTAT (NITROGLYCERIN) TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNITROSTAT (NITROGLYCERIN) TABLET [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNITROSTAT (NITROGLYCERIN) TABLET [A-S MEDICATION SOLUTIONS LLC]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XNITROSTAT (NITROGLYCERIN) TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNITROSTAT (NITROGLYCERIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NITROSTAT (NITROGLYCERIN) TABLET [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NITROSTAT (NITROGLYCERIN) TABLET [A-S MEDICATION SOLUTIONS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NITROSTAT (NITROGLYCERIN) TABLET [AIDAREX PHARMACEUTICALS LLC]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4NITROSTAT (NITROGLYCERIN) TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNITROSTAT (NITROGLYCERIN) TABLET [A-S MEDICATION SOLUTIONS 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
0071-0418NITROSTAT (NITROGLYCERIN) TABLET [PARKE-DAVIS DIV OF PFIZER INC]18Legacy NDC20240606_79ba021e-183c-4b4d-822e-4ff5ef54ca61.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198039nitroglycerin 0.4 MG Sublingual TabletPSNcc481829-0b5a-4e8a-ab5b-cb44d6d2433b5
207346Nitrostat 0.4 MG Sublingual TabletPSNcc481829-0b5a-4e8a-ab5b-cb44d6d2433b5
207346nitroglycerin 0.4 MG Sublingual Tablet [Nitrostat]SBDcc481829-0b5a-4e8a-ab5b-cb44d6d2433b5
198039nitroglycerin 0.4 MG Sublingual TabletSCDcc481829-0b5a-4e8a-ab5b-cb44d6d2433b5
198039nitroglycerin 400 MCG Sublingual TabletSYcc481829-0b5a-4e8a-ab5b-cb44d6d2433b5
207346Nitrostat 0.4 MG Sublingual TabletSYcc481829-0b5a-4e8a-ab5b-cb44d6d2433b5
198039NTG 0.4 MG Sublingual TabletSYcc481829-0b5a-4e8a-ab5b-cb44d6d2433b5
207346NTG 0.4 MG Sublingual Tablet [Nitrostat]SYcc481829-0b5a-4e8a-ab5b-cb44d6d2433b5
198039TNG 0.4 MG Sublingual TabletSYcc481829-0b5a-4e8a-ab5b-cb44d6d2433b5
207346TNG 0.4 MG Sublingual Tablet [Nitrostat]SYcc481829-0b5a-4e8a-ab5b-cb44d6d2433b5
198039nitroglycerin 0.4 MG Sublingual TabletPSN6fe3965f-0dd8-4bae-9771-de25074cb1b03
198039nitroglycerin 0.4 MG Sublingual TabletPSN2d4165c3-169d-5af8-e054-00144ff8d46c3
207346Nitrostat 0.4 MG Sublingual TabletPSN2d4165c3-169d-5af8-e054-00144ff8d46c3
207346Nitrostat 0.4 MG Sublingual TabletPSN6fe3965f-0dd8-4bae-9771-de25074cb1b03
207346nitroglycerin 0.4 MG Sublingual Tablet [Nitrostat]SBD6fe3965f-0dd8-4bae-9771-de25074cb1b03
207346nitroglycerin 0.4 MG Sublingual Tablet [Nitrostat]SBD2d4165c3-169d-5af8-e054-00144ff8d46c3
198039nitroglycerin 0.4 MG Sublingual TabletSCD2d4165c3-169d-5af8-e054-00144ff8d46c3
198039nitroglycerin 0.4 MG Sublingual TabletSCD6fe3965f-0dd8-4bae-9771-de25074cb1b03
198039nitroglycerin 400 MCG Sublingual TabletSY2d4165c3-169d-5af8-e054-00144ff8d46c3
198039nitroglycerin 400 MCG Sublingual TabletSY6fe3965f-0dd8-4bae-9771-de25074cb1b03
207346Nitrostat 0.4 MG Sublingual TabletSY2d4165c3-169d-5af8-e054-00144ff8d46c3
207346Nitrostat 0.4 MG Sublingual TabletSY6fe3965f-0dd8-4bae-9771-de25074cb1b03
198039NTG 0.4 MG Sublingual TabletSY2d4165c3-169d-5af8-e054-00144ff8d46c3
198039NTG 0.4 MG Sublingual TabletSY6fe3965f-0dd8-4bae-9771-de25074cb1b03
207346NTG 0.4 MG Sublingual Tablet [Nitrostat]SY2d4165c3-169d-5af8-e054-00144ff8d46c3
207346NTG 0.4 MG Sublingual Tablet [Nitrostat]SY6fe3965f-0dd8-4bae-9771-de25074cb1b03
198039TNG 0.4 MG Sublingual TabletSY6fe3965f-0dd8-4bae-9771-de25074cb1b03
198039TNG 0.4 MG Sublingual TabletSY2d4165c3-169d-5af8-e054-00144ff8d46c3
207346TNG 0.4 MG Sublingual Tablet [Nitrostat]SY6fe3965f-0dd8-4bae-9771-de25074cb1b03
207346TNG 0.4 MG Sublingual Tablet [Nitrostat]SY2d4165c3-169d-5af8-e054-00144ff8d46c3
198038nitroglycerin 0.3 MG Sublingual TabletPSNb32d82ee-7727-4501-a858-a8304135b11b1
198039nitroglycerin 0.4 MG Sublingual TabletPSNdcb552c1-310a-48af-81ad-a74530531dee1
198039nitroglycerin 0.4 MG Sublingual TabletPSN3d426e54-489b-4ef7-be06-16762877ce741
198039nitroglycerin 0.4 MG Sublingual TabletPSNb32d82ee-7727-4501-a858-a8304135b11b1
207331Nitrostat 0.3 MG Sublingual TabletPSNb32d82ee-7727-4501-a858-a8304135b11b1
207346Nitrostat 0.4 MG Sublingual TabletPSNdcb552c1-310a-48af-81ad-a74530531dee1
207346Nitrostat 0.4 MG Sublingual TabletPSN3d426e54-489b-4ef7-be06-16762877ce741
207346Nitrostat 0.4 MG Sublingual TabletPSNb32d82ee-7727-4501-a858-a8304135b11b1
207331nitroglycerin 0.3 MG Sublingual Tablet [Nitrostat]SBDb32d82ee-7727-4501-a858-a8304135b11b1
207346nitroglycerin 0.4 MG Sublingual Tablet [Nitrostat]SBDdcb552c1-310a-48af-81ad-a74530531dee1
207346nitroglycerin 0.4 MG Sublingual Tablet [Nitrostat]SBD3d426e54-489b-4ef7-be06-16762877ce741
207346nitroglycerin 0.4 MG Sublingual Tablet [Nitrostat]SBDb32d82ee-7727-4501-a858-a8304135b11b1
198038nitroglycerin 0.3 MG Sublingual TabletSCDb32d82ee-7727-4501-a858-a8304135b11b1
198039nitroglycerin 0.4 MG Sublingual TabletSCDdcb552c1-310a-48af-81ad-a74530531dee1
198039nitroglycerin 0.4 MG Sublingual TabletSCDb32d82ee-7727-4501-a858-a8304135b11b1
198039nitroglycerin 0.4 MG Sublingual TabletSCD3d426e54-489b-4ef7-be06-16762877ce741
198038nitroglycerin 300 MCG Sublingual TabletSYb32d82ee-7727-4501-a858-a8304135b11b1
198039nitroglycerin 400 MCG Sublingual TabletSYdcb552c1-310a-48af-81ad-a74530531dee1
198039nitroglycerin 400 MCG Sublingual TabletSY3d426e54-489b-4ef7-be06-16762877ce741
198039nitroglycerin 400 MCG Sublingual TabletSYb32d82ee-7727-4501-a858-a8304135b11b1
207331Nitrostat 0.3 MG Sublingual TabletSYb32d82ee-7727-4501-a858-a8304135b11b1
207346Nitrostat 0.4 MG Sublingual TabletSYb32d82ee-7727-4501-a858-a8304135b11b1
207346Nitrostat 0.4 MG Sublingual TabletSYdcb552c1-310a-48af-81ad-a74530531dee1
207346Nitrostat 0.4 MG Sublingual TabletSY3d426e54-489b-4ef7-be06-16762877ce741
198038NTG 0.3 MG Sublingual TabletSYb32d82ee-7727-4501-a858-a8304135b11b1
207331NTG 0.3 MG Sublingual Tablet [Nitrostat]SYb32d82ee-7727-4501-a858-a8304135b11b1
198039NTG 0.4 MG Sublingual TabletSY3d426e54-489b-4ef7-be06-16762877ce741
198039NTG 0.4 MG Sublingual TabletSYdcb552c1-310a-48af-81ad-a74530531dee1
198039NTG 0.4 MG Sublingual TabletSYb32d82ee-7727-4501-a858-a8304135b11b1
207346NTG 0.4 MG Sublingual Tablet [Nitrostat]SY3d426e54-489b-4ef7-be06-16762877ce741
207346NTG 0.4 MG Sublingual Tablet [Nitrostat]SYb32d82ee-7727-4501-a858-a8304135b11b1
207346NTG 0.4 MG Sublingual Tablet [Nitrostat]SYdcb552c1-310a-48af-81ad-a74530531dee1
198038TNG 0.3 MG Sublingual TabletSYb32d82ee-7727-4501-a858-a8304135b11b1
207331TNG 0.3 MG Sublingual Tablet [Nitrostat]SYb32d82ee-7727-4501-a858-a8304135b11b1
198039TNG 0.4 MG Sublingual TabletSYb32d82ee-7727-4501-a858-a8304135b11b1
198039TNG 0.4 MG Sublingual TabletSY3d426e54-489b-4ef7-be06-16762877ce741
198039TNG 0.4 MG Sublingual TabletSYdcb552c1-310a-48af-81ad-a74530531dee1
207346TNG 0.4 MG Sublingual Tablet [Nitrostat]SY3d426e54-489b-4ef7-be06-16762877ce741
207346TNG 0.4 MG Sublingual Tablet [Nitrostat]SYb32d82ee-7727-4501-a858-a8304135b11b1
207346TNG 0.4 MG Sublingual Tablet [Nitrostat]SYdcb552c1-310a-48af-81ad-a74530531dee1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0071-0418-13000710418134 BOTTLE in 1 CARTON (0071-0418-13) > 25 TABLET in 1 BOTTLE4 bottle2000-05-010000-00-00NoNoCurrent
0071-0418-24000710418241 BOTTLE in 1 CARTON (0071-0418-24) > 100 TABLET in 1 BOTTLE1 bottle2000-05-010000-00-00NoNoCurrent