Isosorbide Mononitrate
- Product NDC
- 50090-5572
- Requested package NDC
- 50090-5572-0
- 11-digit product format
- 500905572
- Labeler code
- 50090
- Product ID
- 50090-5572_fdeb2f81-58ce-43af-aaa4-215a72126254
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Mononitrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA210918
- Marketing category
- ANDA
- Marketing start
- 2018-11-13
- 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
- 2022-12-31
- 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 package | package | 50090-5572 | 50090-5572-0 | 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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210918-001 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | |
| A210918-002 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | |
| A210918-003 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2018-11-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210918-001 | AB |
| A210918-002 | AB |
| A210918-003 | 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 | A210918-001 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210918-002 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210918-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2018-11-05 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A210918-001 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210918-002 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210918-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2018-11-05 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210918-001 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210918-002 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210918-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2018-11-05 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210918-001 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210918-002 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210918-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2018-11-05 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210918-001 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210918-002 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210918-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2018-11-05 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210918-001 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210918-002 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210918-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2018-11-05 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210918-001 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210918-002 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210918-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2018-11-05 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210918-001 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210918-002 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210918-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2018-11-05 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210918-001 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210918-002 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210918-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2018-11-05 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210918-001 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210918-002 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210918-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2018-11-05 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210918-001 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210918-002 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210918-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2018-11-05 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210918-001 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210918-002 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210918-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2018-11-05 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210918-001 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210918-002 | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210918-003 | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2018-11-05 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210918-001 | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-05 | 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 | A210918-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210918-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210918-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A210918-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210918-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210918-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210918-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210918-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210918-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210918-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210918-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210918-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210918-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210918-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210918-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210918-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210918-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210918-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210918-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210918-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210918-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210918-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210918-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210918-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210918-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210918-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210918-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210918-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210918-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210918-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210918-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210918-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210918-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210918-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210918-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210918-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210918-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210918-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210918-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210918-001 | 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 |
|---|---|---|---|---|---|
| 50090-5572-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-eca9-0266-e053-dadaa90a7c1a | Isosorbide Mononitrate Extended-Release Tablets, USP |
| 50090-5572-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-eca9-0266-e053-dadaa90a7c1a | Isosorbide Mononitrate Extended-Release Tablets, USP |
| 50090-5572-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-eca9-0266-e053-dadaa90a7c1a | Isosorbide Mononitrate Extended-Release Tablets, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-5572-0 | Isosorbide Mononitrate | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 1 | |
| 50090-5572-1 | Isosorbide Mononitrate | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 1 | |
| 50090-5572-2 | Isosorbide Mononitrate | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-5572 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS] | 1 | Legacy NDC, 3 package rows | 20210710_bbbb2dda-b68e-4cae-bec5-04a4d8f1f40b.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Northwind Health Company, LLC | df5fd5e2-3a7b-5a5b-e053-2995a90a0dd3 | 2026-01-01 | Warnings, Adverse reactions | 210918 ANDA210918 |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Golden State Medical Supply, Inc. | 86be0e85-5337-bee4-e053-2a91aa0a8158 | 2024-11-11 | Warnings, Adverse reactions | 210918 ANDA210918 |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Aphena Pharma Solutions - Tennessee, LLC | 17525ff2-9ec0-15a1-e063-6394a90ab762 | 2024-04-30 | Warnings, Adverse reactions | 210918 ANDA210918 |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Bryant Ranch Prepack | 441ddd35-6cb8-44d0-8009-1635390ede83 | 2024-04-03 | Warnings, Adverse reactions | 210918 ANDA210918 |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Aphena Pharma Solutions - Tennessee, LLC | 0af6c67f-919d-4515-8074-f6c3aaa835b5 | 2024-02-06 | Warnings, Adverse reactions | 210918 ANDA210918 |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Aphena Pharma Solutions - Tennessee, LLC | 18cf36bc-e73f-4274-b381-c2f2aa02f57d | 2024-02-06 | Warnings, Adverse reactions | 210918 ANDA210918 |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | A-S Medication Solutions | adcca9b8-0505-4bbc-81ab-05efc7407b6b | 2024-01-23 | Warnings, Adverse reactions | 210918 ANDA210918 |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | A-S Medication Solutions | 4da5a0ac-574d-48ea-80ba-55344bfefb91 | 2023-12-09 | Warnings, Adverse reactions | 210918 ANDA210918 |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Ingenus Pharmaceuticals, LLC | c950760f-0e32-483f-96f2-eecaf057c0ec | 2023-10-27 | Warnings, Adverse reactions | 210918 ANDA210918 |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Bryant Ranch Prepack | 96420729-2bc7-4d03-9c51-f786ea678998 | 2023-10-26 | Warnings, Adverse reactions | 210918 ANDA210918 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 353538 | isosorbide mononitrate 60 MG 24HR Extended Release Oral Tablet | PSN | bbbb2dda-b68e-4cae-bec5-04a4d8f1f40b | 1 |
| 353538 | 24 HR isosorbide mononitrate 60 MG Extended Release Oral Tablet | SCD | bbbb2dda-b68e-4cae-bec5-04a4d8f1f40b | 1 |
| 353538 | isosorbide mononitrate 60 MG 24 HR Extended Release Oral Tablet | SY | bbbb2dda-b68e-4cae-bec5-04a4d8f1f40b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-5572-0 | 50090557200 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5572-0) | 2021-06-28 | 0000-00-00 | No | No | Current |