Isosorbide
- Product NDC
- 59115-130
- 11-digit product format
- 591150130
- Labeler code
- 59115
- Product ID
- 59115-130_7bd8087a-3345-4959-8e53-588ea1782bda
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Dinitrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceutical
- Application
- ANDA088088
- Marketing category
- ANDA
- Marketing start
- 1983-04-26
- Marketing end
- 0000-00-00
- Substance
- ISOSORBIDE DINITRATE
- Active strength
- 20 mg/1
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A088088-001 | ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | |
| A088088-002 | ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 10MG | TABLET / ORAL | AB | 1987-10-29 | |
| A088088-003 | ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 5MG | TABLET / ORAL | AB | 1987-10-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A088088-001 | AB |
| A088088-002 | AB |
| A088088-003 | AB |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A088088-002 | ISOSORBIDE DINITRATE | 10MG | TABLET / ORAL | AB | 1987-10-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A088088-003 | ISOSORBIDE DINITRATE | 5MG | TABLET / ORAL | AB | 1987-10-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A088088-002 | ISOSORBIDE DINITRATE | 10MG | TABLET / ORAL | AB | 1987-10-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A088088-003 | ISOSORBIDE DINITRATE | 5MG | TABLET / ORAL | AB | 1987-10-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088088-002 | ISOSORBIDE DINITRATE | 10MG | TABLET / ORAL | AB | 1987-10-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088088-003 | ISOSORBIDE DINITRATE | 5MG | TABLET / ORAL | AB | 1987-10-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A088088-002 | ISOSORBIDE DINITRATE | 10MG | TABLET / ORAL | AB | 1987-10-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A088088-003 | ISOSORBIDE DINITRATE | 5MG | TABLET / ORAL | AB | 1987-10-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A088088-001 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 1987-11-02 | a72a2bbeb626… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A088088-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A088088-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A088088-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A088088-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A088088-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A088088-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088088-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088088-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088088-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A088088-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A088088-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A088088-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088088-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088088-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088088-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088088-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088088-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088088-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A088088-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088088-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088088-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A088088-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A088088-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A088088-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A088088-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A088088-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A088088-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A088088-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A088088-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A088088-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A088088-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A088088-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A088088-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A088088-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A088088-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A088088-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A088088-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A088088-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A088088-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A088088-001 | AB | 1 | a72a2bbeb626… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Isosorbide Dinitrate | ISOSORBIDE DINITRATE | Cardinal Health 107, LLC | 5f585259-59ed-4648-b562-164f3746c821 | 2026-05-19 | Warnings, Adverse reactions | 088088 ANDA088088 |
| Isosorbide Dinitrate | ISOSORBIDE DINITRATE | Major Pharmaceuticals | 6c4997e7-9ce6-46a6-a9c1-4bd3d76155eb | 2026-03-13 | Warnings, Adverse reactions | 088088 ANDA088088 |
| Isosorbide Dinitrate | ISOSORBIDE DINITRATE | Golden State Medical Supply, Inc. | 7f860fbd-f130-4652-e053-2991aa0a402e | 2026-01-08 | Warnings, Adverse reactions | 088088 ANDA088088 |
| Isosorbide Dinitrate | ISOSORBIDE DINITRATE | Hikma Pharmaceuticals USA Inc. | f0b9b320-0bf8-4342-b654-135ccb6755c2 | 2025-12-05 | Warnings, Adverse reactions | 088088 ANDA088088 |
| Isosorbide | ISOSORBIDE DINITRATE | BluePoint Laboratories | 9498fa14-1614-4a8e-b872-41c11745b01e | 2018-11-30 | Warnings, Adverse reactions | 088088 ANDA088088 |