FDA.reportPublic FDA data

Isosorbide

Product NDC
0143-2230
11-digit product format
001432230
Labeler code
0143
Product ID
0143-2230_3a032922-f0d8-45d9-9c76-5a1bcc4b9b6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide mononitrate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA076813
Marketing category
ANDA
Marketing start
2006-03-30
Marketing end
2020-12-31
Substance
ISOSORBIDE MONONITRATE
Active strength
30 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-2230-01EA - Each0143-2230a0b23a97-bef5-44b7-92d7-04749156417e12012-07-24
0143-2230-10EA - Each0143-2230be733539-aeef-43eb-9994-7289e144335412012-07-24

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 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