ISOSORBIDE MONONITRATE

Product NDC
68382-652
11-digit product format
683820652
Labeler code
68382
Product ID
68382-652_0f30ef5c-bdf6-4823-8483-8d40cfe4e460
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isosorbide mononitrate
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA075395
Marketing category
ANDA
Marketing start
2013-12-19
Marketing end
0000-00-00
Substance
ISOSORBIDE MONONITRATE
Active strength
120 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
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
68382-652-012022-07-29C16284748780-1e4f33bdf-9b5a-d8a0-e053-dadaa90a6e4eIsosorbide Mononitrate Extended-Release Tablets 30 mg, 60 mg, and 120 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-652-01ISOSORBIDE MONONITRATE100 in 1 BOTTLETABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-652-01EA - Each68382-652d09e5623-baec-4ba7-b065-aa6611328baa12014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOSORBIDE MONONITRATEACTIVE INGREDIENTLX1OH63030ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
ISOSORBIDE MONONITRATEACTIVE MOIETYLX1OH63030ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-652ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC. ]7Legacy NDC, 1 package rows20211218_897a0327-25d4-4769-bd6a-0e674264017f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311196isosorbide mononitrate 120 MG 24HR Extended Release Oral TabletPSN897a0327-25d4-4769-bd6a-0e674264017f7
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSN897a0327-25d4-4769-bd6a-0e674264017f7
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSN897a0327-25d4-4769-bd6a-0e674264017f7
31119624 HR isosorbide mononitrate 120 MG Extended Release Oral TabletSCD897a0327-25d4-4769-bd6a-0e674264017f7
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCD897a0327-25d4-4769-bd6a-0e674264017f7
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCD897a0327-25d4-4769-bd6a-0e674264017f7
311196isosorbide mononitrate 120 MG 24 HR Extended Release Oral TabletSY897a0327-25d4-4769-bd6a-0e674264017f7
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSY897a0327-25d4-4769-bd6a-0e674264017f7
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSY897a0327-25d4-4769-bd6a-0e674264017f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-652-0168382065201100 TABLET in 1 BOTTLE (68382-652-01) 100 tablet2013-12-190000-00-00NoNoCurrent