Isosorbide dinitrate
- Product NDC
- 70518-3444
- 11-digit product format
- 705183444
- Labeler code
- 70518
- Product ID
- 70518-3444_ea5f62cf-aa0c-fbc6-e053-2a95a90a9f5f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide dinitrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA213057
- Marketing category
- ANDA
- Marketing start
- 2022-06-29
- Marketing end
- 0000-00-00
- Substance
- ISOSORBIDE DINITRATE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 70518-3444 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 70518-3444 | 70518-3444-0 | D | Discontinued by firm | 2026-08-17 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-3444-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-3444-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70518-3444-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70518-3444-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70518-3444-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70518-3444-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70518-3444-0 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70518-3444-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-3444-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70518-3444-0 | ad56d346431e… | cc804d4bbf1e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213057-001 | ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 5MG | TABLET / ORAL | AB | 2019-11-20 | |
| A213057-002 | ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 10MG | TABLET / ORAL | AB | 2019-11-20 | |
| A213057-003 | ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 2019-11-20 | |
| A213057-004 | ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 30MG | TABLET / ORAL | AB | 2019-11-20 | |
| A213057-005 | ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 40MG | TABLET / ORAL | AB | 2019-11-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213057-001 | AB |
| A213057-002 | AB |
| A213057-003 | AB |
| A213057-004 | AB |
| A213057-005 | 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 | A213057-001 | ISOSORBIDE DINITRATE | 5MG | TABLET / ORAL | AB | 2019-11-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213057-002 | ISOSORBIDE DINITRATE | 10MG | TABLET / ORAL | AB | 2019-11-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213057-003 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 2019-11-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213057-004 | ISOSORBIDE DINITRATE | 30MG | TABLET / ORAL | AB | 2019-11-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213057-005 | ISOSORBIDE DINITRATE | 40MG | TABLET / ORAL | AB | 2019-11-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213057-001 | ISOSORBIDE DINITRATE | 5MG | TABLET / ORAL | AB | 2019-11-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213057-002 | ISOSORBIDE DINITRATE | 10MG | TABLET / ORAL | AB | 2019-11-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213057-003 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 2019-11-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213057-004 | ISOSORBIDE DINITRATE | 30MG | TABLET / ORAL | AB | 2019-11-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213057-005 | ISOSORBIDE DINITRATE | 40MG | TABLET / ORAL | AB | 2019-11-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213057-001 | ISOSORBIDE DINITRATE | 5MG | TABLET / ORAL | AB | 2019-11-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213057-002 | ISOSORBIDE DINITRATE | 10MG | TABLET / ORAL | AB | 2019-11-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213057-003 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 2019-11-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213057-004 | ISOSORBIDE DINITRATE | 30MG | TABLET / ORAL | AB | 2019-11-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213057-005 | ISOSORBIDE DINITRATE | 40MG | TABLET / ORAL | AB | 2019-11-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213057-001 | ISOSORBIDE DINITRATE | 5MG | TABLET / ORAL | AB | 2019-11-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213057-002 | ISOSORBIDE DINITRATE | 10MG | TABLET / ORAL | AB | 2019-11-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213057-003 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 2019-11-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213057-004 | ISOSORBIDE DINITRATE | 30MG | TABLET / ORAL | AB | 2019-11-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213057-005 | ISOSORBIDE DINITRATE | 40MG | TABLET / ORAL | AB | 2019-11-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213057-001 | ISOSORBIDE DINITRATE | 5MG | TABLET / ORAL | AB | 2019-11-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213057-002 | ISOSORBIDE DINITRATE | 10MG | TABLET / ORAL | AB | 2019-11-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213057-003 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 2019-11-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213057-004 | ISOSORBIDE DINITRATE | 30MG | TABLET / ORAL | AB | 2019-11-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213057-005 | ISOSORBIDE DINITRATE | 40MG | TABLET / ORAL | AB | 2019-11-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213057-001 | ISOSORBIDE DINITRATE | 5MG | TABLET / ORAL | AB | 2019-11-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213057-002 | ISOSORBIDE DINITRATE | 10MG | TABLET / ORAL | AB | 2019-11-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213057-003 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 2019-11-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213057-004 | ISOSORBIDE DINITRATE | 30MG | TABLET / ORAL | AB | 2019-11-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213057-005 | ISOSORBIDE DINITRATE | 40MG | TABLET / ORAL | AB | 2019-11-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213057-001 | ISOSORBIDE DINITRATE | 5MG | TABLET / ORAL | AB | 2019-11-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213057-002 | ISOSORBIDE DINITRATE | 10MG | TABLET / ORAL | AB | 2019-11-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213057-003 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 2019-11-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213057-004 | ISOSORBIDE DINITRATE | 30MG | TABLET / ORAL | AB | 2019-11-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213057-005 | ISOSORBIDE DINITRATE | 40MG | TABLET / ORAL | AB | 2019-11-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213057-001 | ISOSORBIDE DINITRATE | 5MG | TABLET / ORAL | AB | 2019-11-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213057-002 | ISOSORBIDE DINITRATE | 10MG | TABLET / ORAL | AB | 2019-11-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213057-003 | ISOSORBIDE DINITRATE | 20MG | TABLET / ORAL | AB | 2019-11-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213057-004 | ISOSORBIDE DINITRATE | 30MG | TABLET / ORAL | AB | 2019-11-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213057-005 | ISOSORBIDE DINITRATE | 40MG | TABLET / ORAL | AB | 2019-11-20 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A213057-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213057-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213057-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213057-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213057-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A213057-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213057-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213057-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213057-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213057-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213057-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213057-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213057-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213057-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213057-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213057-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213057-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213057-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213057-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213057-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213057-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213057-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213057-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213057-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213057-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213057-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213057-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213057-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213057-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213057-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213057-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213057-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213057-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213057-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213057-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213057-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213057-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213057-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213057-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213057-005 | AB | 1 | 2680178bc6a6… |
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 | Northstar Rx LLC | 246c749d-aa28-44ce-8d42-984660afff2a | 2025-08-21 | Warnings, Adverse reactions | 213057 ANDA213057 |
| Isosorbide dinitrate | ISOSORBIDE DINITRATE | BluePoint Laboratories | f1d52e9a-8de1-61db-e053-2a95a90aae50 | 2024-09-17 | Warnings, Adverse reactions | 213057 ANDA213057 |
| Isosorbide dinitrate | ISOSORBIDE DINITRATE | Zydus Pharmaceuticals (USA) Inc. | 16818b32-ee5e-4e07-b848-31e892c4b98a | 2024-08-08 | Warnings, Adverse reactions | 213057 ANDA213057 |
| Isosorbide dinitrate | ISOSORBIDE DINITRATE | Zydus Lifesciences Limited | 5b0db8af-bcf9-458f-b752-420130cba428 | 2023-11-07 | Warnings, Adverse reactions | 213057 ANDA213057 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-3444-0 | 70518344400 | 30 TABLET in 1 BLISTER PACK (70518-3444-0) | 30 tablet | 2022-06-29 | 0000-00-00 | No | No | Current |