isosorbide mononitrate

Product NDC
62175-129
11-digit product format
621750129
Labeler code
62175
Product ID
62175-129_6d91cd6b-f0bf-4e23-97b2-8c659e6f8475
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isosorbide mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA075155
Marketing category
ANDA
Marketing start
1998-10-30
Marketing end
2024-03-31
Substance
ISOSORBIDE MONONITRATE
Active strength
120 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
62175-129-37EA - Each62175-129a3f059bc-1fc0-4b25-94b6-dbf8ac6fffe612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOSORBIDE MONONITRATEACTIVE INGREDIENTLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
ISOSORBIDEACTIVE MOIETYWXR179L51SISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
ISOSORBIDE MONONITRATEACTIVE MOIETYLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
ISOSORBIDE MONONITRATEACTIVE INGREDIENTLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ISOSORBIDE MONONITRATEACTIVE INGREDIENTLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
ISOSORBIDEACTIVE MOIETYWXR179L51SISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
ISOSORBIDE MONONITRATEACTIVE MOIETYLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311196isosorbide mononitrate 120 MG 24HR Extended Release Oral TabletPSN07c1c818-44ad-44b0-aeec-2bc51193cd523
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSN07c1c818-44ad-44b0-aeec-2bc51193cd523
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSN07c1c818-44ad-44b0-aeec-2bc51193cd523
31119624 HR isosorbide mononitrate 120 MG Extended Release Oral TabletSCD07c1c818-44ad-44b0-aeec-2bc51193cd523
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCD07c1c818-44ad-44b0-aeec-2bc51193cd523
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCD07c1c818-44ad-44b0-aeec-2bc51193cd523
311196isosorbide mononitrate 120 MG 24 HR Extended Release Oral TabletSY07c1c818-44ad-44b0-aeec-2bc51193cd523
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSY07c1c818-44ad-44b0-aeec-2bc51193cd523
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSY07c1c818-44ad-44b0-aeec-2bc51193cd523
311196isosorbide mononitrate 120 MG 24HR Extended Release Oral TabletPSNc4e579c9-2f31-4d5b-bac2-1261626277b22
31119624 HR isosorbide mononitrate 120 MG Extended Release Oral TabletSCDc4e579c9-2f31-4d5b-bac2-1261626277b22
311196isosorbide mononitrate 120 MG 24 HR Extended Release Oral TabletSYc4e579c9-2f31-4d5b-bac2-1261626277b22
311196isosorbide mononitrate 120 MG 24HR Extended Release Oral TabletPSNcc6293ae-1f81-4670-84b2-c00422c690ca1
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSNcc6293ae-1f81-4670-84b2-c00422c690ca1
31119624 HR isosorbide mononitrate 120 MG Extended Release Oral TabletSCDcc6293ae-1f81-4670-84b2-c00422c690ca1
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCDcc6293ae-1f81-4670-84b2-c00422c690ca1
311196isosorbide mononitrate 120 MG 24 HR Extended Release Oral TabletSYcc6293ae-1f81-4670-84b2-c00422c690ca1
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSYcc6293ae-1f81-4670-84b2-c00422c690ca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62175-129-3762175012937100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-129-37) 1998-10-302024-03-31NoNoCurrent
62175-129-43621750129431000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-129-43) 1998-10-302024-03-31NoNoCurrent