isosorbide mononitrate

Product NDC
21695-575
11-digit product format
216950575
Labeler code
21695
Product ID
21695-575_f3516a1d-6f30-42b5-9a7a-07ccff7c58d6
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
30 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-575-30isosorbide mononitrate30 in 1 BOTTLETABLET, EXTENDED RELEASE302
21695-575-90isosorbide mononitrate90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-575-30EA - Each21695-5753f2fb628-b87e-42d4-9d28-05c67b69dfcd12012-07-24
21695-575-90EA - Each21695-575dd7a71d0-7c07-4338-a3a4-e2f205a2fb4012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOSORBIDE MONONITRATEACTIVE INGREDIENTLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
ISOSORBIDEACTIVE MOIETYWXR179L51SISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-575ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2Legacy NDC, 2 package rows20110629_8c104eaa-d2ec-4403-84a7-8d93b585698e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSN8c104eaa-d2ec-4403-84a7-8d93b585698e2
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCD8c104eaa-d2ec-4403-84a7-8d93b585698e2
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSY8c104eaa-d2ec-4403-84a7-8d93b585698e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-575-302169505753030 in 1 BOTTLEHistorical
21695-575-902169505759090 in 1 BOTTLEHistorical