Isosorbide Mononitrate

Product NDC
70518-2122
11-digit product format
705182122
Labeler code
70518
Product ID
70518-2122_eadb8cf2-6ddd-4e78-e053-2995a90aff14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075522
Marketing category
ANDA
Marketing start
2019-05-29
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
2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-2122DDiscontinued by firm2026-08-17
excluded packagepackage70518-212270518-2122-0DDiscontinued by firm2026-08-17
excluded packagepackage70518-212270518-2122-1DDiscontinued 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 · 22 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 packagepackage70518-2122-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-2122-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-2122-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-2122-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-2122-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-2122-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-2122-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-2122-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-2122-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-2122-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-2122-00efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-2122-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-2122-0ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-2122-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-2122-0367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-2122-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-2122-1557ba5c1ecfa…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
A075522-001ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2000-04-17
A075522-002ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2016-09-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075522-001AB
A075522-002AB

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 06:07:402026-07A075522-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2000-04-17caaa826d4ba7…
2026-08-18 06:07:402026-07A075522-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2016-09-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075522-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2000-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075522-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2016-09-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075522-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2000-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075522-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2016-09-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A075522-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2000-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075522-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2016-09-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075522-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2000-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075522-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2016-09-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075522-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2000-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075522-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2016-09-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075522-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2000-04-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075522-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2016-09-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075522-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2000-04-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075522-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2016-09-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075522-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2000-04-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075522-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2016-09-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075522-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2000-04-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075522-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2016-09-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075522-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2000-04-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A075522-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2016-09-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075522-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2000-04-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075522-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2016-09-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075522-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2000-04-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075522-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2016-09-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075522-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2000-04-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075522-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2016-09-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075522-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2000-04-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075522-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2016-09-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075522-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2000-04-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075522-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2016-09-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075522-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2000-04-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075522-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2016-09-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075522-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2000-04-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075522-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2016-09-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075522-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2000-04-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075522-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2016-09-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075522-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2000-04-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075522-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2016-09-20bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075522-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075522-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075522-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075522-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075522-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075522-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075522-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075522-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075522-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075522-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075522-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075522-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075522-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075522-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075522-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075522-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075522-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075522-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075522-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075522-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075522-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075522-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075522-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075522-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075522-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075522-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075522-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075522-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075522-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075522-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075522-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075522-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075522-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075522-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075522-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075522-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075522-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075522-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075522-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075522-002AB1bb7c543d1eb4…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2122ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]13Legacy NDC20250308_3c3699d1-b012-438b-8027-986962e318ac.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isosorbide MononitrateISOSORBIDE MONONITRATECoupler LLC46b3030d-f492-da9d-e063-6294a90a31b32025-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075522
application number: ANDA075522
Isosorbide MononitrateISOSORBIDE MONONITRATEChartwell RX, LLCb38f43c8-d02d-4aee-ab23-e898cbfadfbc2025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075522
application number: ANDA075522
Isosorbide MononitrateISOSORBIDE MONONITRATEBryant Ranch Prepackcd60ded0-01d9-4a51-a8ad-cdfeb27d88fb2025-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075522
application number: ANDA075522
Isosorbide MononitrateISOSORBIDE MONONITRATEEdenbridge Pharmaceuticals LLC.0e3c4461-2e04-481f-a9e5-29f21cc71ec52025-06-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075522
application number: ANDA075522
Isosorbide MononitrateISOSORBIDE MONONITRATENuCare Pharmaceuticals,Inc.65935a15-a023-1941-e053-2991aa0a5eb42024-06-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075522
application number: ANDA075522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2122-07051821220030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-2122-0) 2019-05-290000-00-00NoNoCurrent
70518-2122-17051821220190 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2122-1) 2019-07-100000-00-00NoNoCurrent