FDA.reportPublic FDA data

ISOSORBIDE MONONITRATE

Product NDC
70518-2956
11-digit product format
705182956
Labeler code
70518
Product ID
70518-2956_4ab9f8a1-dca0-d354-e063-6394a90ae775
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ISOSORBIDE MONONITRATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA200270
Marketing category
ANDA
Marketing start
2020-12-03
Substance
ISOSORBIDE MONONITRATE
Active strength
30 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ISOSORBIDE MONONITRATE
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2956-02022-02-10C16284748780-1d6a99b3a-00da-a426-e053-dadaa90af4c2Isosorbide Mononitrate Extended-Release Tablets, USP Rx only
70518-2956-02022-01-28C16284748780-1d6a99b3a-00da-a426-e053-dadaa90af4c2Isosorbide Mononitrate Extended-Release Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2956-0ISOSORBIDE MONONITRATE30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE308
70518-2956-1ISOSORBIDE MONONITRATE30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2956ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]6Current NDC, Legacy NDC, 2 package rows20250406_d01d4f0f-5164-4ea3-b772-72b97961c6fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSNd01d4f0f-5164-4ea3-b772-72b97961c6fb8
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCDd01d4f0f-5164-4ea3-b772-72b97961c6fb8
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSYd01d4f0f-5164-4ea3-b772-72b97961c6fb8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2956-07051829560030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-2956-0) 2020-12-030000-00-00NoNoCurrent
70518-2956-17051829560130 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-2956-1) 2024-12-17NoNoCurrent