isosorbide mononitrate

Product NDC
21695-777
11-digit product format
216950777
Labeler code
21695
Product ID
21695-777_cc6293ae-1f81-4670-84b2-c00422c690ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isosorbide mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA075155
Marketing category
ANDA
Marketing start
1998-10-30
Marketing end
0000-00-00
Substance
ISOSORBIDE MONONITRATE
Active strength
120 mg/1
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
cc3f7505-fd5d-aab9-1128-173349f98a63Product name420230113
f23201a1-1f10-4748-0041-3c03fbb37cfbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-777-302019-09-24C16284748780-1934fe258-481e-48b1-e053-8cdaa90a720aIsosorbide Mononitrate Extended-Release Tablets Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-777-30isosorbide mononitrate30 in 1 BOTTLETABLET, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-777-30EA - Each21695-777e929a4b3-af54-4f1b-a670-467c5973ca4912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOSORBIDE MONONITRATEACTIVE INGREDIENTLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
ISOSORBIDEACTIVE MOIETYWXR179L51SISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-777ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110706_cc6293ae-1f81-4670-84b2-c00422c690ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311196isosorbide mononitrate 120 MG 24HR Extended Release Oral TabletPSNcc6293ae-1f81-4670-84b2-c00422c690ca1
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSNcc6293ae-1f81-4670-84b2-c00422c690ca1
31119624 HR isosorbide mononitrate 120 MG Extended Release Oral TabletSCDcc6293ae-1f81-4670-84b2-c00422c690ca1
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCDcc6293ae-1f81-4670-84b2-c00422c690ca1
311196isosorbide mononitrate 120 MG 24 HR Extended Release Oral TabletSYcc6293ae-1f81-4670-84b2-c00422c690ca1
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSYcc6293ae-1f81-4670-84b2-c00422c690ca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-777-302169507773030 in 1 BOTTLEHistorical