Isosorbide

Product NDC
71335-0739
11-digit product format
713350739
Labeler code
71335
Product ID
71335-0739_ed6ddad6-f876-41ea-8fec-518e69487ca5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide mononitrate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076813
Marketing category
ANDA
Marketing start
2006-03-30
Marketing end
0000-00-00
Substance
ISOSORBIDE MONONITRATE
Active strength
30 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct71335-0739DDiscontinued by firm2026-08-17
excluded packagepackage71335-073971335-0739-1DDiscontinued by firm2026-08-17
excluded packagepackage71335-073971335-0739-2DDiscontinued by firm2026-08-17
excluded packagepackage71335-073971335-0739-3DDiscontinued by firm2026-08-17
excluded packagepackage71335-073971335-0739-4DDiscontinued by firm2026-08-17

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 packagepackage71335-0739-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0739-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0739-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0739-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0739-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0739-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0739-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0739-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0739-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0739-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0739-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0739-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0739-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0739-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0739-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0739-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0739-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0739-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0739-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0739-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0739-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0739-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0739-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0739-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0739-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0739-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0739-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0739-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-0739-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-0739-4ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-0739-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-0739-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-0739-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-0739-40efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-0739-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-0739-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-0739-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-0739-4ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-0739-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-0739-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-0739-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-0739-4367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-0739-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-0739-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-0739-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-0739-4557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-0739-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-0739-2557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076813-001ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2005-01-07
A076813-002ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2006-03-30

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076813-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2005-01-07caaa826d4ba7…
2026-08-18 06:07:402026-07A076813-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2006-03-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076813-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2005-01-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076813-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2006-03-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076813-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2005-01-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076813-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2006-03-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076813-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2005-01-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076813-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2006-03-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076813-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2005-01-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076813-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2006-03-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076813-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2005-01-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076813-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2006-03-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076813-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2005-01-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076813-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2006-03-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076813-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2005-01-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076813-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2006-03-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076813-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2005-01-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076813-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2006-03-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076813-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2005-01-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076813-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2006-03-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076813-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2005-01-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A076813-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2006-03-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076813-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2005-01-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076813-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2006-03-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076813-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2005-01-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076813-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2006-03-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076813-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2005-01-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076813-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2006-03-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076813-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2005-01-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076813-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2006-03-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076813-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2005-01-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076813-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2006-03-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076813-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2005-01-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076813-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2006-03-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076813-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2005-01-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076813-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2006-03-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076813-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2005-01-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076813-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2006-03-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076813-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORAL2005-01-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076813-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORAL2006-03-30bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076813-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076813-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A076813-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076813-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076813-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076813-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076813-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076813-002AB1ea99ee380514…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0739-17133507390130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0739-1) 2018-03-200000-00-00NoNoCurrent
71335-0739-27133507390290 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0739-2) 2018-03-200000-00-00NoNoCurrent
71335-0739-37133507390360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0739-3) 2018-03-200000-00-00NoNoCurrent
71335-0739-471335073904120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0739-4) 2018-03-200000-00-00NoNoCurrent