FDA.reportPublic FDA data

Isosorbide Mononitrate

Product NDC
42799-958
11-digit product format
427990958
Labeler code
42799
Product ID
42799-958_aaebe3ce-b7d9-4114-aacb-a3c778360549
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Edenbridge Pharmaceuticals LLC.
Application
ANDA075522
Marketing category
ANDA
Marketing start
2017-01-05
Substance
ISOSORBIDE MONONITRATE
Active strength
30 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 MONONITRATE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLX1OH63030
Rxcui317110, 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
42799-958-01Isosorbide Mononitrate100 in 1 BOTTLETABLET, EXTENDED RELEASE1003
42799-958-02Isosorbide Mononitrate500 in 1 BOTTLETABLET, EXTENDED RELEASE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42799-958-01EA - Each42799-958797a13fd-8462-4bee-ba4f-959ccc9a303112023-07-06
42799-958-02EA - Each42799-958c76744e9-f0fd-479a-9bc7-6eecbcdb9faa12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42799-958ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [EDENBRIDGE PHARMACEUTICALS LLC.]1Current NDC, 2 package rows20230629_0e3c4461-2e04-481f-a9e5-29f21cc71ec5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSN0e3c4461-2e04-481f-a9e5-29f21cc71ec53
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSN0e3c4461-2e04-481f-a9e5-29f21cc71ec53
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCD0e3c4461-2e04-481f-a9e5-29f21cc71ec53
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCD0e3c4461-2e04-481f-a9e5-29f21cc71ec53
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSY0e3c4461-2e04-481f-a9e5-29f21cc71ec53
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSY0e3c4461-2e04-481f-a9e5-29f21cc71ec53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42799-958-0142799095801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42799-958-01) 2023-07-01NoNoHistorical
42799-958-0242799095802500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42799-958-02) 2023-07-01NoNoHistorical