Isosorbide Mononitrate

Product NDC
0603-4110
11-digit product format
006034110
Labeler code
0603
Product ID
0603-4110_4a86d677-edfd-4901-b857-d0b6a92c170e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Par Pharmaceutical
Application
ANDA090598
Marketing category
ANDA
Marketing start
2010-08-11
Marketing end
2019-10-31
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0603-4110DDiscontinued by firm2026-08-03
excluded packagepackage0603-41100603-4110-10DDiscontinued by firm2026-08-03
excluded packagepackage0603-41100603-4110-21DDiscontinued by firm2026-08-03
excluded packagepackage0603-41100603-4110-28DDiscontinued by firm2026-08-03
excluded packagepackage0603-41100603-4110-32DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 60 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0603-4110-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0603-4110-32d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0603-4110-28d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0603-4110-21d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0603-4110-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0603-4110-32f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0603-4110-28f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0603-4110-21f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0603-4110-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0603-4110-322ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0603-4110-282ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0603-4110-212ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0603-4110-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0603-4110-32a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0603-4110-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0603-4110-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0603-4110-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0603-4110-32cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0603-4110-28cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0603-4110-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0603-4110-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0603-4110-32cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0603-4110-28cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0603-4110-21cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0603-4110-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0603-4110-32302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0603-4110-28302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0603-4110-21302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0603-4110-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0603-4110-32ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0603-4110-28ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0603-4110-21ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0603-4110-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0603-4110-320efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0603-4110-280efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0603-4110-210efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0603-4110-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0603-4110-32ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0603-4110-28ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0603-4110-21ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0603-4110-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0603-4110-32367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0603-4110-28367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0603-4110-21367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0603-4110-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0603-4110-32557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0603-4110-28557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0603-4110-21557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090598-001ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2010-08-11
A090598-002ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2010-08-11
A090598-003ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORAL2010-08-11

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090598-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2010-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090598-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2010-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090598-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORAL2010-08-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090598-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2010-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090598-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2010-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090598-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORAL2010-08-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090598-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2010-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090598-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2010-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090598-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORAL2010-08-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090598-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2010-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090598-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2010-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090598-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORAL2010-08-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090598-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2010-08-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090598-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2010-08-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090598-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORAL2010-08-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090598-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2010-08-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090598-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2010-08-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090598-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORAL2010-08-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090598-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2010-08-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090598-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2010-08-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090598-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORAL2010-08-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090598-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2010-08-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090598-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2010-08-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090598-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORAL2010-08-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090598-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2010-08-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090598-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2010-08-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090598-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORAL2010-08-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090598-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2010-08-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A090598-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2010-08-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A090598-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORAL2010-08-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090598-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2010-08-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090598-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2010-08-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090598-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORAL2010-08-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090598-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2010-08-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090598-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2010-08-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090598-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORAL2010-08-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090598-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2010-08-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090598-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2010-08-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090598-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORAL2010-08-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090598-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2010-08-118072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A090598-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090598-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090598-003AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A090598-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A090598-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A090598-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090598-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090598-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090598-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090598-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090598-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090598-003AB1ea99ee380514…

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
0603-4110-21EA - Each0603-4110f05c567c-65c8-4f87-a2cb-b843b095770612012-07-24
0603-4110-28EA - Each0603-41103920ec14-a6d1-48a0-ac75-df6b6556856412012-07-24
0603-4110-32EA - Each0603-411099081510-2b62-4549-a661-c07328bdb4f012012-07-24

DailyMed Socrata Ingredients#

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSNb14cd7e5-48ea-4f24-ac01-1635f43f3e038
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSNb14cd7e5-48ea-4f24-ac01-1635f43f3e038
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCDb14cd7e5-48ea-4f24-ac01-1635f43f3e038
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCDb14cd7e5-48ea-4f24-ac01-1635f43f3e038
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSYb14cd7e5-48ea-4f24-ac01-1635f43f3e038
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSYb14cd7e5-48ea-4f24-ac01-1635f43f3e038