FDA.reportPublic FDA data

isosorbide mononitrate

Product NDC
67544-224
Requested package NDC
67544-224-82
11-digit product format
675440224
Labeler code
67544
Product ID
67544-224_12d1eedc-151a-4775-8e83-9f64e967cb70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isosorbide mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075155
Marketing category
ANDA
Marketing start
1998-10-30
Marketing end
0000-00-00
Substance
ISOSORBIDE MONONITRATE
Active strength
60 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage67544-22467544-224-82IInactivated 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075155-001ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-10-30
A075155-002ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2000-01-13
A075155-003ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALAB2000-08-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A075155-001AB
A075155-002AB
A075155-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075155-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-10-30caaa826d4ba7…
2026-08-18 06:07:402026-07A075155-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2000-01-13caaa826d4ba7…
2026-08-18 06:07:402026-07A075155-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALAB2000-08-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075155-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-10-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075155-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2000-01-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075155-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALAB2000-08-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075155-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-10-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075155-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2000-01-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075155-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALAB2000-08-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A075155-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-10-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075155-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2000-01-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075155-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALAB2000-08-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075155-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-10-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075155-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2000-01-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075155-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALAB2000-08-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075155-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-10-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075155-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2000-01-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075155-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALAB2000-08-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075155-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-10-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075155-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2000-01-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075155-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALAB2000-08-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075155-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-10-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075155-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2000-01-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075155-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALAB2000-08-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075155-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-10-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075155-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2000-01-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075155-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALAB2000-08-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075155-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-10-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075155-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2000-01-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075155-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALAB2000-08-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075155-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-10-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A075155-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2000-01-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A075155-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALAB2000-08-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075155-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-10-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075155-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2000-01-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075155-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALAB2000-08-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075155-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-10-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075155-002ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2000-01-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075155-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALAB2000-08-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075155-001ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB1998-10-301e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075155-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075155-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075155-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075155-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075155-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075155-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075155-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075155-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075155-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075155-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075155-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075155-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075155-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075155-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075155-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075155-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075155-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075155-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075155-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075155-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075155-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075155-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075155-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075155-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075155-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075155-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075155-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075155-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075155-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075155-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075155-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075155-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075155-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075155-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075155-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075155-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075155-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075155-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075155-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075155-001AB11e350fbaab3a…

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#

NDC, Related label table
NDCRelated label
67544-224-30Isosorbide Mononitrate Extended-Release Tablets Rx only
67544-224-45Isosorbide Mononitrate Extended-Release Tablets Rx only
67544-224-56Isosorbide Mononitrate Extended-Release Tablets Rx only
67544-224-60Isosorbide Mononitrate Extended-Release Tablets Rx only
67544-224-80Isosorbide Mononitrate Extended-Release Tablets Rx only
67544-224-81Isosorbide Mononitrate Extended-Release Tablets Rx only
67544-224-82Isosorbide Mononitrate Extended-Release Tablets Rx only
67544-224-99Isosorbide Mononitrate Extended-Release Tablets Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-224-30isosorbide mononitrate30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE303
67544-224-45isosorbide mononitrate45 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE453
67544-224-56isosorbide mononitrate3000 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE30003
67544-224-60isosorbide mononitrate90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE903
67544-224-80isosorbide mononitrate180 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1803
67544-224-81isosorbide mononitrate800 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE8003
67544-224-82isosorbide mononitrate1200 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE12003
67544-224-99isosorbide mononitrate600 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE6003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-224-30EA - Each67544-2249a66b9ce-9914-4bcb-9387-80318bde9b6212014-05-02
67544-224-45EA - Each67544-22404a64ad6-8d71-48f4-a8ea-5695e78d794412014-05-02
67544-224-56EA - Each67544-22444c3cf7a-105a-4110-bbef-e7ed1e92f46412014-06-03
67544-224-60EA - Each67544-224f558c5a2-f5dd-4b29-813d-2c0361ea62c012014-05-02
67544-224-80EA - Each67544-224c24899c3-5862-4c86-a52b-e5e5b53d9a9512014-05-02
67544-224-81EA - Each67544-2246f1d5a5f-a4ea-4b17-9059-a30dcd6271aa12014-09-03
67544-224-82EA - Each67544-224ec661ed4-24be-412e-9a89-38800ef7236612014-09-03
67544-224-99EA - Each67544-224557095bb-a848-4215-9238-7eeaf4fbada812014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOSORBIDE MONONITRATEACTIVE INGREDIENTLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
ISOSORBIDE MONONITRATEACTIVE MOIETYLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-224ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Legacy NDC, 8 package rows20191224_a707727c-819f-43ea-89f3-2a2ae1cb9edf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSNa707727c-819f-43ea-89f3-2a2ae1cb9edf3
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCDa707727c-819f-43ea-89f3-2a2ae1cb9edf3
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSYa707727c-819f-43ea-89f3-2a2ae1cb9edf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67544-224-82675440224821200 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-224-82) 2005-12-060000-00-00NoNoCurrent