FDA.reportPublic FDA data

NITROLINGUAL

Product NDC
70007-300
11-digit product format
700070300
Labeler code
70007
Product ID
70007-300_806a9c83-efeb-4862-acec-0fc43839e23d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitroglycerin
Dosage form
SPRAY
Route
ORAL
Labeler
Espero Pharmaceuticals, Inc.
Application
NDA018705
Marketing category
NDA
Marketing start
2016-03-01
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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
00358076-c817-430b-b924-11d717dc307cProduct name120160718
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70007-300-202020-01-31C16284748780-19d75b9d0-0af3-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NITROLINGUAL® PUMPSPRAY safely and effectively. See full prescribing information for NITROLINGUAL PUMPSPRAY. NITROLINGUAL® PUMPSPRAY (nitroglycerin) lingual spray Initial U.S. Approval: 1997
70007-300-652020-01-31C16284748780-19d75b9d0-0af3-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NITROLINGUAL® PUMPSPRAY safely and effectively. See full prescribing information for NITROLINGUAL PUMPSPRAY. NITROLINGUAL® PUMPSPRAY (nitroglycerin) lingual spray Initial U.S. Approval: 1997

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70007-300-20GM - Gram70007-300dd14af1c-5125-42b7-a047-59aa065e2b1a12016-11-08
70007-300-65GM - Gram70007-30035db30df-dee3-4730-9460-a3c8a4d8bc8612016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70007-300NITROLINGUAL (NITROGLYCERIN) SPRAY [ESPERO PHARMACEUTICALS, INC.]5Legacy NDC20180809_2b7c772a-adef-4eef-bb83-aaa798e1b712.zip