Isosorbide Mononitrate

Product NDC
50090-4047
Requested package NDC
50090-4047-0
11-digit product format
500904047
Labeler code
50090
Product ID
50090-4047_19c08063-f9b8-4052-88a7-2efeda86a527
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075522
Marketing category
ANDA
Marketing start
2017-01-05
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
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-404750090-4047-0IInactivated by FDA2026-08-17

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cc3f7505-fd5d-aab9-1128-173349f98a63Product name420230113
f23201a1-1f10-4748-0041-3c03fbb37cfbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4047-0Isosorbide Mononitrate30 in 1 BOTTLETABLET, EXTENDED RELEASE305
50090-4047-1Isosorbide Mononitrate100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1005
50090-4047-2Isosorbide Mononitrate90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4047-0EA - Each50090-4047fb33fd12-9434-489b-9b61-99d19b7848fa12022-01-06
50090-4047-1EA - Each50090-4047659dbb07-547f-4875-8afe-d472a1d6d50812022-01-06
50090-4047-2EA - Each50090-4047d6cfd7c1-92e8-440c-a736-4d9d8176750c12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4047ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]5Legacy NDC, 3 package rows20210417_00270f4b-53e4-482b-9f99-aee57ace7831.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSN00270f4b-53e4-482b-9f99-aee57ace78315
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCD00270f4b-53e4-482b-9f99-aee57ace78315
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSY00270f4b-53e4-482b-9f99-aee57ace78315

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4047-05009040470030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4047-0) 2019-01-110000-00-00NoNoCurrent