FDA.reportPublic FDA data

Isosorbide Mononitrate

Product NDC
62135-588
11-digit product format
621350588
Labeler code
62135
Product ID
62135-588_44fde4f9-0086-6476-e063-6394a90a6a92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA210822
Marketing category
ANDA
Marketing start
2018-11-15
Substance
ISOSORBIDE MONONITRATE
Active strength
120 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Isosorbide Mononitrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOSORBIDE MONONITRATE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLX1OH63030
Rxcui311196, 317110, 353538

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cc3f7505-fd5d-aab9-1128-173349f98a63Product name420230113
f23201a1-1f10-4748-0041-3c03fbb37cfbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-588-90Isosorbide Mononitrate90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-588-90EA - Each62135-5882f7a140b-8329-4b54-b91a-71b81279b86112023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-588ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [CHARTWELL RX, LLC]2Current NDC, 1 package rows20241030_b38f43c8-d02d-4aee-ab23-e898cbfadfbc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311196isosorbide mononitrate 120 MG 24HR Extended Release Oral TabletPSNb38f43c8-d02d-4aee-ab23-e898cbfadfbc3
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSNb38f43c8-d02d-4aee-ab23-e898cbfadfbc3
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSNb38f43c8-d02d-4aee-ab23-e898cbfadfbc3
31119624 HR isosorbide mononitrate 120 MG Extended Release Oral TabletSCDb38f43c8-d02d-4aee-ab23-e898cbfadfbc3
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCDb38f43c8-d02d-4aee-ab23-e898cbfadfbc3
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCDb38f43c8-d02d-4aee-ab23-e898cbfadfbc3
311196isosorbide mononitrate 120 MG 24 HR Extended Release Oral TabletSYb38f43c8-d02d-4aee-ab23-e898cbfadfbc3
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSYb38f43c8-d02d-4aee-ab23-e898cbfadfbc3
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSYb38f43c8-d02d-4aee-ab23-e898cbfadfbc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62135-588-906213505889090 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-588-90) 2023-04-26NoNoCurrent