FDA.reportPublic FDA data

Isosorbide Mononitrate

Product NDC
71610-788
11-digit product format
716100788
Labeler code
71610
Product ID
71610-788_ed4b9b65-54be-40f0-b2d0-452b7d1b49c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA210918
Marketing category
ANDA
Marketing start
2018-11-05
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

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
71610-788-30Isosorbide Mononitrate30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE302
71610-788-60Isosorbide Mononitrate90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-788-30EA - Each71610-7887c31b58f-f270-429c-a0fb-9c54f0bee1e812024-03-12
71610-788-60EA - Each71610-788101017c8-e078-486c-b484-1dd2eae506be12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-788ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, 2 package rows20240207_18cf36bc-e73f-4274-b381-c2f2aa02f57d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSN18cf36bc-e73f-4274-b381-c2f2aa02f57d2
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCD18cf36bc-e73f-4274-b381-c2f2aa02f57d2
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSY18cf36bc-e73f-4274-b381-c2f2aa02f57d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-788-307161007883030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-788-30) 2024-02-05NoNoHistorical
71610-788-607161007886090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-788-60) 2024-02-05NoNoHistorical