Isosorbide

Product NDC
68151-1418
11-digit product format
681511418
Labeler code
68151
Product ID
68151-1418_37641f76-c88d-4779-989a-cda49959450c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide mononitrate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA076813
Marketing category
ANDA
Marketing start
2006-03-30
Marketing end
0000-00-00
Substance
ISOSORBIDE MONONITRATE
Active strength
30 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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
68151-1418-02020-01-31C16284748780-19d75b9d1-0fc3-f424-e053-dadaa90a57ceIsosorbide Mononitrate ER Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-1418-0Isosorbide1 in 1 PACKAGETABLET, FILM COATED, EXTENDED RE14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOSORBIDE MONONITRATEACTIVE INGREDIENTLX1OH63030ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
ISOSORBIDE MONONITRATEACTIVE MOIETYLX1OH63030ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
AMMONIUM PHOSPHATE, DIBASICINACTIVE INGREDIENT10LGE70FSUISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-1418ISOSORBIDE (ISOSORBIDE MONONITRATE) TABLET, FILM COATED, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]4Legacy NDC, 1 package rows20170706_f8b3465a-d884-4a24-9b4e-87aa2df6f7d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSNf8b3465a-d884-4a24-9b4e-87aa2df6f7d24
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCDf8b3465a-d884-4a24-9b4e-87aa2df6f7d24
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSYf8b3465a-d884-4a24-9b4e-87aa2df6f7d24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-1418-0681511418001 in 1 PACKAGEHistorical