FDA.reportPublic FDA data

GONITRO

Product NDC
70007-400
11-digit product format
700070400
Labeler code
70007
Product ID
70007-400_677e8d16-0bd2-4cc5-8d23-98e9cc0cf676
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitroglycerin
Dosage form
POWDER
Route
SUBLINGUAL
Labeler
Espero Pharmaceuticals, Inc.
Application
NDA208424
Marketing category
NDA
Marketing start
2016-07-01
Marketing end
0000-00-00
Substance
NITROGLYCERIN
Active strength
400 ug/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
70007-400-122020-01-31C16284748780-19d75b9d0-8f4a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GONITRO safely and effectively. See full prescribing information for GONITRO . GONITRO (nitroglycerin) sublingual powder Initial U.S. Approval: 1981
70007-400-362020-01-31C16284748780-19d75b9d0-8f4a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GONITRO safely and effectively. See full prescribing information for GONITRO . GONITRO (nitroglycerin) sublingual powder Initial U.S. Approval: 1981
70007-400-962020-01-31C16284748780-19d75b9d0-8f4a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GONITRO safely and effectively. See full prescribing information for GONITRO . GONITRO (nitroglycerin) sublingual powder Initial U.S. Approval: 1981
70007-400-992020-01-31C16284748780-19d75b9d0-8f4a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GONITRO safely and effectively. See full prescribing information for GONITRO . GONITRO (nitroglycerin) sublingual powder Initial U.S. Approval: 1981

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70007-400-01EA - Each70007-400ea2f4bfe-a23c-4eb7-b6cf-0418be4279b812016-10-06
70007-400-36EA - Each70007-40019f02220-a503-4c7d-9b12-37e5f9b7309b12016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70007-400GONITRO (NITROGLYCERIN) POWDER [ESPERO PHARMACEUTICALS, INC.]4Legacy NDC20180803_1418d832-4a6a-45ab-8414-25e23f393abb.zip