Isosorbide Dinitrate

Product NDC
0143-1769
11-digit product format
001431769
Labeler code
0143
Product ID
0143-1769_9be99742-a98b-46d3-9447-81b45679fff9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Dinitrate
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA088088
Marketing category
ANDA
Marketing start
1978-12-01
Substance
ISOSORBIDE DINITRATE
Active strength
5 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
A088088-001ISOSORBIDE DINITRATEISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-02
A088088-002ISOSORBIDE DINITRATEISOSORBIDE DINITRATE10MGTABLET / ORALAB1987-10-29
A088088-003ISOSORBIDE DINITRATEISOSORBIDE DINITRATE5MGTABLET / ORALAB1987-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A088088-001AB
A088088-002AB
A088088-003AB

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 2 · 52 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-02caaa826d4ba7…
2026-08-18 06:07:402026-07A088088-002ISOSORBIDE DINITRATE10MGTABLET / ORALAB1987-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07A088088-003ISOSORBIDE DINITRATE5MGTABLET / ORALAB1987-10-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A088088-002ISOSORBIDE DINITRATE10MGTABLET / ORALAB1987-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A088088-003ISOSORBIDE DINITRATE5MGTABLET / ORALAB1987-10-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088088-002ISOSORBIDE DINITRATE10MGTABLET / ORALAB1987-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088088-003ISOSORBIDE DINITRATE5MGTABLET / ORALAB1987-10-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A088088-002ISOSORBIDE DINITRATE10MGTABLET / ORALAB1987-10-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A088088-003ISOSORBIDE DINITRATE5MGTABLET / ORALAB1987-10-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-023f01610625f2…
2019-09-15 20:21 UTC2019-09A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088088-001ISOSORBIDE DINITRATE20MGTABLET / ORALAB1987-11-02a72a2bbeb626…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A088088-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A088088-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A088088-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A088088-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A088088-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A088088-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088088-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088088-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088088-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A088088-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A088088-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A088088-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088088-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088088-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088088-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088088-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088088-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088088-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088088-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088088-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088088-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088088-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088088-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088088-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088088-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088088-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088088-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088088-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088088-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088088-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A088088-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088088-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088088-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088088-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A088088-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A088088-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088088-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088088-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088088-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088088-001AB1a72a2bbeb626…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOSORBIDE DINITRATE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IA7306519NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
206842Internal RxNorm lookup
314055Internal RxNorm lookup
381056Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f0b9b320-0bf8-4342-b654-135ccb6755c2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e9ed2ee5-d109-4795-bffe-c3b047717749Product name220250107
1ee44c84-1ad7-16b4-788d-a549f91b0f44Product name420230316
0dcc68a5-df0d-b1a6-ba71-3da99d94ffe9Product name120140508
b0c258c1-3fb1-4785-4031-5c4417fb7ecdProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-1769-01Isosorbide Dinitrate100 in 1 BOTTLE, PLASTICTABLET10031
0143-1769-10Isosorbide Dinitrate1000 in 1 BOTTLE, PLASTICTABLET100031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-1769-01EA - Each0143-1769cc395fb4-f959-40b7-9d6e-fe36a1a3bcd012012-07-24
0143-1769-10EA - Each0143-176909394c70-8925-4078-95a2-40c6760e3ffe12012-07-24
0143-1769-25EA - Each0143-176973488a09-f6ac-46e6-b1ff-1be61d1607ca12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOSORBIDE DINITRATEACTIVE INGREDIENTIA7306519NISOSORBIDE DINITRATE TABLET [WEST-WARD PHARMACEUTICALS CORP]14
ISOSORBIDE DINITRATEACTIVE MOIETYIA7306519NISOSORBIDE DINITRATE TABLET [WEST-WARD PHARMACEUTICALS CORP]14
AMMONIUM PHOSPHATE, DIBASICINACTIVE INGREDIENT10LGE70FSUISOSORBIDE DINITRATE TABLET [WEST-WARD PHARMACEUTICALS CORP]14
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKISOSORBIDE DINITRATE TABLET [WEST-WARD PHARMACEUTICALS CORP]14
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UISOSORBIDE DINITRATE TABLET [WEST-WARD PHARMACEUTICALS CORP]14
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GISOSORBIDE DINITRATE TABLET [WEST-WARD PHARMACEUTICALS CORP]14
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDISOSORBIDE DINITRATE TABLET [WEST-WARD PHARMACEUTICALS CORP]14
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ISOSORBIDE DINITRATE TABLET [WEST-WARD PHARMACEUTICALS CORP]14
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ISOSORBIDE DINITRATE TABLET [WEST-WARD PHARMACEUTICALS CORP]14
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ISOSORBIDE DINITRATE TABLET [WEST-WARD PHARMACEUTICALS CORP]14
ISOSORBIDE DINITRATEACTIVE INGREDIENTIA7306519NISOSORBIDE DINITRATE TABLET [CARILION MATERIALS MANAGEMENT]2
ISOSORBIDE DINITRATEACTIVE MOIETYIA7306519NISOSORBIDE DINITRATE TABLET [CARILION MATERIALS MANAGEMENT]2
AMMONIUM PHOSPHATE, DIBASICINACTIVE INGREDIENT10LGE70FSUISOSORBIDE DINITRATE TABLET [CARILION MATERIALS MANAGEMENT]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKISOSORBIDE DINITRATE TABLET [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UISOSORBIDE DINITRATE TABLET [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ISOSORBIDE DINITRATE TABLET [CARILION MATERIALS MANAGEMENT]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ISOSORBIDE DINITRATE TABLET [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-1769ISOSORBIDE DINITRATE TABLET [HIKMA PHARMACEUTICALS USA INC.]30Current NDC, Legacy NDC, 2 package rows20231229_f0b9b320-0bf8-4342-b654-135ccb6755c2.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 DinitrateISOSORBIDE DINITRATECardinal Health 107, LLC5f585259-59ed-4648-b562-164f3746c8212026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088088
application number: ANDA088088
Isosorbide DinitrateISOSORBIDE DINITRATEMajor Pharmaceuticals6c4997e7-9ce6-46a6-a9c1-4bd3d76155eb2026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088088
application number: ANDA088088
Isosorbide DinitrateISOSORBIDE DINITRATEGolden State Medical Supply, Inc.7f860fbd-f130-4652-e053-2991aa0a402e2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088088
application number: ANDA088088
Isosorbide DinitrateISOSORBIDE DINITRATEHikma Pharmaceuticals USA Inc.f0b9b320-0bf8-4342-b654-135ccb6755c22025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088088
application number: ANDA088088
ndc (product): 0143-1769
IsosorbideISOSORBIDE DINITRATEBluePoint Laboratories9498fa14-1614-4a8e-b872-41c11745b01e2018-11-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088088
application number: ANDA088088

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
381056isosorbide dinitrate 10 MG Oral TabletPSNf0b9b320-0bf8-4342-b654-135ccb6755c231
206842isosorbide dinitrate 20 MG Oral TabletPSNf0b9b320-0bf8-4342-b654-135ccb6755c231
314055isosorbide dinitrate 5 MG Oral TabletPSNf0b9b320-0bf8-4342-b654-135ccb6755c231
381056isosorbide dinitrate 10 MG Oral TabletSCDf0b9b320-0bf8-4342-b654-135ccb6755c231
206842isosorbide dinitrate 20 MG Oral TabletSCDf0b9b320-0bf8-4342-b654-135ccb6755c231
314055isosorbide dinitrate 5 MG Oral TabletSCDf0b9b320-0bf8-4342-b654-135ccb6755c231
381056ISDN 10 MG Oral TabletSYf0b9b320-0bf8-4342-b654-135ccb6755c231
206842ISDN 20 MG Oral TabletSYf0b9b320-0bf8-4342-b654-135ccb6755c231
314055ISDN 5 MG Oral TabletSYf0b9b320-0bf8-4342-b654-135ccb6755c231
381056isosorbide dinitrate 10 MG Oral TabletPSN7f860fbd-f130-4652-e053-2991aa0a402e7
206842isosorbide dinitrate 20 MG Oral TabletPSN7f860fbd-f130-4652-e053-2991aa0a402e7
314055isosorbide dinitrate 5 MG Oral TabletPSN7f860fbd-f130-4652-e053-2991aa0a402e7
381056isosorbide dinitrate 10 MG Oral TabletSCD7f860fbd-f130-4652-e053-2991aa0a402e7
206842isosorbide dinitrate 20 MG Oral TabletSCD7f860fbd-f130-4652-e053-2991aa0a402e7
314055isosorbide dinitrate 5 MG Oral TabletSCD7f860fbd-f130-4652-e053-2991aa0a402e7
381056ISDN 10 MG Oral TabletSY7f860fbd-f130-4652-e053-2991aa0a402e7
206842ISDN 20 MG Oral TabletSY7f860fbd-f130-4652-e053-2991aa0a402e7
314055ISDN 5 MG Oral TabletSY7f860fbd-f130-4652-e053-2991aa0a402e7
314055isosorbide dinitrate 5 MG Oral TabletPSN9e806b87-e67f-4f01-9c22-3b53f9622b342
314055isosorbide dinitrate 5 MG Oral TabletSCD9e806b87-e67f-4f01-9c22-3b53f9622b342
314055ISDN 5 MG Oral TabletSY9e806b87-e67f-4f01-9c22-3b53f9622b342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-1769-0100143176901100 TABLET in 1 BOTTLE, PLASTIC (0143-1769-01) 100 tablet1978-12-010000-00-00NoNoCurrent
0143-1769-10001431769101000 TABLET in 1 BOTTLE, PLASTIC (0143-1769-10) 1000 tablet1978-12-010000-00-00NoNoCurrent