FDA.reportPublic FDA data

ISOSORBIDE MONONITRATE

Product NDC
13668-105
11-digit product format
136680105
Labeler code
13668
Product ID
13668-105_34e0adcc-8899-4abb-bba4-6be95d0ce2dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ISOSORBIDE MONONITRATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA200495
Marketing category
ANDA
Marketing start
2011-06-03
Substance
ISOSORBIDE MONONITRATE
Active strength
60 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 MONONITRATE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLX1OH63030
Rxcui311196, 317110, 353538

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-105-01ISOSORBIDE MONONITRATE100 in 1 BOTTLETABLET, EXTENDED RELEASE10013
13668-105-10ISOSORBIDE MONONITRATE1000 in 1 BOTTLETABLET, EXTENDED RELEASE100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-105-01EA - Each13668-105e7256fd4-1488-43e4-9014-c985ac4cac9912012-07-24
13668-105-05EA - Each13668-10517d3c35f-a904-49cd-91c8-8c0787e9048b12012-07-24
13668-105-10EA - Each13668-10543cdf12c-4dcf-4f1f-93d4-94a9d32c4c5712012-07-24
13668-105-20EA - Each13668-105236add76-29b1-4842-aedf-c6457555962512012-07-24
13668-105-74EA - Each13668-1056b60942e-3815-4706-90ee-212778e5bd5e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOSORBIDE MONONITRATEACTIVE INGREDIENTLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
ISOSORBIDE MONONITRATEACTIVE MOIETYLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
TALCINACTIVE INGREDIENT7SEV7J4R1UISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
ISOSORBIDE MONONITRATEACTIVE INGREDIENTLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
ISOSORBIDE MONONITRATEACTIVE INGREDIENTLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
ISOSORBIDE MONONITRATEACTIVE MOIETYLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
ISOSORBIDE MONONITRATEACTIVE MOIETYLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
HYDROXYPROPYL CELLULOSE (TYPE E)INACTIVE INGREDIENT66O7AQV0RTISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
TALCINACTIVE INGREDIENT7SEV7J4R1UISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
TALCINACTIVE INGREDIENT7SEV7J4R1UISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]3
ISOSORBIDE MONONITRATEACTIVE INGREDIENTLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1
ISOSORBIDE MONONITRATEACTIVE MOIETYLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-105ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]12Current NDC, Legacy NDC, 2 package rows20241025_0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311196isosorbide mononitrate 120 MG 24HR Extended Release Oral TabletPSN0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c13
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSN0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c13
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSN0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c13
31119624 HR isosorbide mononitrate 120 MG Extended Release Oral TabletSCD0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c13
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCD0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c13
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCD0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c13
311196isosorbide mononitrate 120 MG 24 HR Extended Release Oral TabletSY0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c13
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSY0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c13
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSY0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c13
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSNba6120c8-c885-4cfa-b68e-9eee7a3bad6d12
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCDba6120c8-c885-4cfa-b68e-9eee7a3bad6d12
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSYba6120c8-c885-4cfa-b68e-9eee7a3bad6d12
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSN8cbb364a-bafe-454b-a53f-bd7cd69a55938
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSN8cbb364a-bafe-454b-a53f-bd7cd69a55938
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCD8cbb364a-bafe-454b-a53f-bd7cd69a55938
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCD8cbb364a-bafe-454b-a53f-bd7cd69a55938
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSY8cbb364a-bafe-454b-a53f-bd7cd69a55938
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSY8cbb364a-bafe-454b-a53f-bd7cd69a55938
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSN6a582db5-eb45-4320-98c1-55517d7d8c384
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSN6a582db5-eb45-4320-98c1-55517d7d8c384
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCD6a582db5-eb45-4320-98c1-55517d7d8c384
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCD6a582db5-eb45-4320-98c1-55517d7d8c384
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSY6a582db5-eb45-4320-98c1-55517d7d8c384
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSY6a582db5-eb45-4320-98c1-55517d7d8c384
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSN364aab7b-d1f8-4cb1-ad8d-163dcf723c6e1
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCD364aab7b-d1f8-4cb1-ad8d-163dcf723c6e1
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSY364aab7b-d1f8-4cb1-ad8d-163dcf723c6e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13668-105-0113668010501100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-105-01) 2011-06-030000-00-00NoNoCurrent
13668-105-0513668010505500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-105-05) 2011-06-030000-00-00NoNoCurrent
13668-105-10136680105101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-105-10) 2011-06-030000-00-00NoNoCurrent
13668-105-20136680105202000 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-105-20) 2011-06-030000-00-00NoNoCurrent
13668-105-7413668010574100 TABLET, EXTENDED RELEASE in 1 CARTON (13668-105-74) 2011-06-030000-00-00NoNoCurrent