Isosorbide Mononitrate

Product NDC
71335-2192
11-digit product format
713352192
Labeler code
71335
Product ID
71335-2192_79752f3a-c401-46d7-84a5-9383a04c792d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210918
Marketing category
ANDA
Marketing start
2018-11-13
Substance
ISOSORBIDE MONONITRATE
Active strength
60 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A210918-001ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05
A210918-002ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05
A210918-003ISOSORBIDE MONONITRATEISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210918-001AB
A210918-002AB
A210918-003AB

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 06:07:402026-07A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05caaa826d4ba7…
2026-08-18 06:07:402026-07A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05caaa826d4ba7…
2026-08-18 06:07:402026-07A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210918-002ISOSORBIDE MONONITRATE60MGTABLET, EXTENDED RELEASE / ORALAB2018-11-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210918-003ISOSORBIDE MONONITRATE120MGTABLET, EXTENDED RELEASE / ORALABRS2018-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210918-001ISOSORBIDE MONONITRATE30MGTABLET, EXTENDED RELEASE / ORALAB2018-11-051e350fbaab3a…

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 06:07:402026-07A210918-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210918-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210918-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210918-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210918-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210918-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210918-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210918-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210918-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210918-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210918-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210918-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210918-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210918-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210918-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210918-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210918-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210918-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210918-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210918-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210918-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210918-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210918-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210918-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210918-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210918-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210918-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210918-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210918-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210918-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210918-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210918-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210918-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210918-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210918-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210918-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210918-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210918-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210918-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210918-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Isosorbide Mononitrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOSORBIDE MONONITRATE60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LX1OH63030Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
353538Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
96420729-2bc7-4d03-9c51-f786ea678998Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2192-1Isosorbide Mononitrate100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE100102
71335-2192-2Isosorbide Mononitrate30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE30102
71335-2192-3Isosorbide Mononitrate60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE60102
71335-2192-4Isosorbide Mononitrate90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE90102
71335-2192-5Isosorbide Mononitrate10 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE10102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2192-1EA - Each71335-219276fc2d0c-78c4-443b-957f-6151a9b6315f12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2192ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20240608_96420729-2bc7-4d03-9c51-f786ea678998.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isosorbide MononitrateISOSORBIDE MONONITRATENorthwind Health Company, LLCdf5fd5e2-3a7b-5a5b-e053-2995a90a0dd32026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210918
application number: ANDA210918
Isosorbide MononitrateISOSORBIDE MONONITRATEGolden State Medical Supply, Inc.86be0e85-5337-bee4-e053-2a91aa0a81582024-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210918
application number: ANDA210918
Isosorbide MononitrateISOSORBIDE MONONITRATEAphena Pharma Solutions - Tennessee, LLC17525ff2-9ec0-15a1-e063-6394a90ab7622024-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210918
application number: ANDA210918
Isosorbide MononitrateISOSORBIDE MONONITRATEBryant Ranch Prepack441ddd35-6cb8-44d0-8009-1635390ede832024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210918
application number: ANDA210918
Isosorbide MononitrateISOSORBIDE MONONITRATEAphena Pharma Solutions - Tennessee, LLC0af6c67f-919d-4515-8074-f6c3aaa835b52024-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210918
application number: ANDA210918
Isosorbide MononitrateISOSORBIDE MONONITRATEAphena Pharma Solutions - Tennessee, LLC18cf36bc-e73f-4274-b381-c2f2aa02f57d2024-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210918
application number: ANDA210918
Isosorbide MononitrateISOSORBIDE MONONITRATEA-S Medication Solutionsadcca9b8-0505-4bbc-81ab-05efc7407b6b2024-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210918
application number: ANDA210918
Isosorbide MononitrateISOSORBIDE MONONITRATEA-S Medication Solutions4da5a0ac-574d-48ea-80ba-55344bfefb912023-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210918
application number: ANDA210918
Isosorbide MononitrateISOSORBIDE MONONITRATEIngenus Pharmaceuticals, LLCc950760f-0e32-483f-96f2-eecaf057c0ec2023-10-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210918
application number: ANDA210918
Isosorbide MononitrateISOSORBIDE MONONITRATEBryant Ranch Prepack96420729-2bc7-4d03-9c51-f786ea6789982023-10-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210918
application number: ANDA210918
ndc (product): 71335-2192

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSN96420729-2bc7-4d03-9c51-f786ea678998102
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCD96420729-2bc7-4d03-9c51-f786ea678998102
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSY96420729-2bc7-4d03-9c51-f786ea678998102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2192-171335219201100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-1) 2022-12-010000-00-00NoNoCurrent
71335-2192-27133521920230 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-2) 2022-12-010000-00-00NoNoCurrent
71335-2192-37133521920360 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-3) 2022-12-010000-00-00NoNoCurrent
71335-2192-47133521920490 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-4) 2022-12-010000-00-00NoNoCurrent
71335-2192-57133521920510 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-5) 2022-12-010000-00-00NoNoCurrent