FDA.reportPublic FDA data

Isosorbide Mononitrate

Product NDC
60687-794
11-digit product format
606870794
Labeler code
60687
Product ID
60687-794_401e9cbc-19c0-c019-e063-6294a90a1cd8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA200495
Marketing category
ANDA
Marketing start
2023-10-23
Substance
ISOSORBIDE MONONITRATE
Active strength
60 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 MONONITRATE60 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
60687-794-01Isosorbide Mononitrate100 in 1 CARTONTABLET, EXTENDED RELEASE1004
60687-794-11Isosorbide Mononitrate1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-794-01EA - Each60687-79485f129d8-2188-4401-9650-2051a51aba5712023-09-05
60687-794-11EA - Each60687-794c8a48e39-5f57-4f96-bdac-38eab63bd59212023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-794ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3Current NDC, 2 package rows20241220_6a582db5-eb45-4320-98c1-55517d7d8c38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSN6a582db5-eb45-4320-98c1-55517d7d8c384
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSN6a582db5-eb45-4320-98c1-55517d7d8c384
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCD6a582db5-eb45-4320-98c1-55517d7d8c384
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCD6a582db5-eb45-4320-98c1-55517d7d8c384
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSY6a582db5-eb45-4320-98c1-55517d7d8c384
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSY6a582db5-eb45-4320-98c1-55517d7d8c384

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-794-0160687079401100 BLISTER PACK in 1 CARTON (60687-794-01) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-794-11) 100 blister pack2023-10-23NoNoHistorical
60687-794-11606870794111 in 1 BLISTER PACKHistorical