isosorbide mononitrate
- Product NDC
- 50090-2077
- 11-digit product format
- 500902077
- Labeler code
- 50090
- Product ID
- 50090-2077_bf63bf7c-2d05-40b3-b50b-6054ea40415b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- isosorbide mononitrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- 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
- 2019-12-31
- 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 | 50090-2077 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 50090-2077 | 50090-2077-0 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 50090-2077 | 50090-2077-1 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 50090-2077 | 50090-2077-2 | I | Inactivated by FDA | 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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-2077-1 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-2077-2 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-2077-0 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-2077-1 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-2077-2 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-2077-0 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50090-2077-1 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50090-2077-2 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50090-2077-0 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50090-2077-1 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50090-2077-2 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50090-2077-0 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50090-2077-1 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50090-2077-2 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50090-2077-0 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50090-2077-1 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50090-2077-2 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50090-2077-0 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50090-2077-1 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50090-2077-2 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50090-2077-0 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50090-2077-1 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50090-2077-2 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50090-2077-0 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50090-2077-1 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50090-2077-2 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50090-2077-0 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50090-2077-1 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50090-2077-2 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50090-2077-0 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50090-2077-1 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50090-2077-2 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50090-2077-0 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50090-2077-1 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50090-2077-2 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50090-2077-0 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50090-2077-2 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50090-2077-0 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50090-2077-2 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50090-2077-0 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50090-2077-2 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50090-2077-0 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 50090-2077-2 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 50090-2077-0 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075155-001 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-10-30 | |
| A075155-002 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-01-13 | |
| A075155-003 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-08-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075155-001 | AB |
| A075155-002 | AB |
| A075155-003 | 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 | A075155-001 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-10-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075155-002 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-01-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075155-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-08-04 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075155-001 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-10-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075155-002 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-01-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075155-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-08-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075155-001 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-10-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075155-002 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-01-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075155-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-08-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075155-001 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-10-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075155-002 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-01-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075155-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-08-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075155-001 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-10-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075155-002 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-01-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075155-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-08-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075155-001 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-10-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075155-002 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-01-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075155-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-08-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075155-001 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-10-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075155-002 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-01-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075155-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-08-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075155-001 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-10-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075155-002 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-01-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075155-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-08-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075155-001 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-10-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075155-002 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-01-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075155-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-08-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075155-001 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-10-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075155-002 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-01-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075155-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-08-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075155-001 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-10-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075155-002 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-01-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075155-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-08-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075155-001 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-10-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075155-002 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-01-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075155-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-08-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075155-001 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-10-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075155-002 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-01-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075155-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2000-08-04 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075155-001 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-10-30 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A075155-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075155-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075155-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075155-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075155-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075155-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075155-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075155-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075155-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075155-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075155-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075155-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075155-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075155-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075155-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075155-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075155-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075155-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075155-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075155-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075155-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075155-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075155-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075155-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075155-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075155-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075155-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075155-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075155-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075155-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075155-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075155-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075155-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075155-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075155-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075155-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075155-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075155-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075155-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075155-001 | AB | 1 | 1e350fbaab3a… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cc3f7505-fd5d-aab9-1128-173349f98a63 | Product name | 4 | 20230113 |
| f23201a1-1f10-4748-0041-3c03fbb37cfb | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-2077-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6c1f-f424-e053-dadaa90a57ce | Isosorbide Mononitrate Extended-Release Tablets Rx only |
| 50090-2077-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6c1f-f424-e053-dadaa90a57ce | Isosorbide Mononitrate Extended-Release Tablets Rx only |
| 50090-2077-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6c1f-f424-e053-dadaa90a57ce | Isosorbide Mononitrate Extended-Release Tablets Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-2077-0 | isosorbide mononitrate | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 5 | |
| 50090-2077-1 | isosorbide mononitrate | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 5 | |
| 50090-2077-2 | isosorbide mononitrate | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-2077-0 | EA - Each | 50090-2077 | 6f15805a-e314-47ac-943c-a1c10fb9e651 | 1 | 2019-02-13 |
| 50090-2077-1 | EA - Each | 50090-2077 | d99dd1d8-e4f8-4ca1-bfe4-20d1b93d9ad5 | 1 | 2019-02-13 |
| 50090-2077-2 | EA - Each | 50090-2077 | 64069ef1-fa05-4ccb-9646-682d84774052 | 1 | 2018-11-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-2077 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS] | 5 | Legacy NDC, 3 package rows | 20181211_b14942c1-6162-4582-bc2c-2ff07a344dbd.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 353538 | isosorbide mononitrate 60 MG 24HR Extended Release Oral Tablet | PSN | b14942c1-6162-4582-bc2c-2ff07a344dbd | 5 |
| 353538 | 24 HR isosorbide mononitrate 60 MG Extended Release Oral Tablet | SCD | b14942c1-6162-4582-bc2c-2ff07a344dbd | 5 |
| 353538 | isosorbide mononitrate 60 MG 24 HR Extended Release Oral Tablet | SY | b14942c1-6162-4582-bc2c-2ff07a344dbd | 5 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50090-2077-0 | 50090207700 | 30 in 1 BOTTLE | Historical |
| 50090-2077-1 | 50090207701 | 100 in 1 BOTTLE | Historical |
| 50090-2077-2 | 50090207702 | 90 in 1 BOTTLE | Historical |