Isosorbide Mononitrate
- Product NDC
- 50090-2554
- 11-digit product format
- 500902554
- Labeler code
- 50090
- Product ID
- 50090-2554_378b4a07-1231-44ca-9446-236457770ff0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Mononitrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA090598
- Marketing category
- ANDA
- Marketing start
- 2010-08-11
- Marketing end
- 0000-00-00
- Substance
- ISOSORBIDE MONONITRATE
- Active strength
- 30 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
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 |
|---|---|---|---|---|---|
| 50090-2554-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e0cf-f424-e053-dadaa90a57ce | ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS USP 30 mg, 60 mg, and 120 mg |
| 50090-2554-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e0cf-f424-e053-dadaa90a57ce | ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS USP 30 mg, 60 mg, and 120 mg |
| 50090-2554-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e0cf-f424-e053-dadaa90a57ce | ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS USP 30 mg, 60 mg, and 120 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-2554-0 | Isosorbide Mononitrate | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 8 | |
| 50090-2554-1 | Isosorbide Mononitrate | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 8 | |
| 50090-2554-2 | Isosorbide Mononitrate | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-2554-0 | EA - Each | 50090-2554 | 5f5015ee-a7ba-4f41-80d3-cf65a5cd843c | 1 | 2019-03-12 |
| 50090-2554-1 | EA - Each | 50090-2554 | 23edef89-2aec-4aa0-be3e-f861748c0bf7 | 1 | 2019-03-12 |
| 50090-2554-2 | EA - Each | 50090-2554 | 07c87055-565e-4032-8397-8459eb19b272 | 1 | 2018-11-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-2554 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS] | 8 | Legacy NDC, 3 package rows | 20190225_b14cd7e5-48ea-4f24-ac01-1635f43f3e03.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 317110 | isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet | PSN | b14cd7e5-48ea-4f24-ac01-1635f43f3e03 | 8 |
| 353538 | isosorbide mononitrate 60 MG 24HR Extended Release Oral Tablet | PSN | b14cd7e5-48ea-4f24-ac01-1635f43f3e03 | 8 |
| 317110 | 24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet | SCD | b14cd7e5-48ea-4f24-ac01-1635f43f3e03 | 8 |
| 353538 | 24 HR isosorbide mononitrate 60 MG Extended Release Oral Tablet | SCD | b14cd7e5-48ea-4f24-ac01-1635f43f3e03 | 8 |
| 317110 | isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet | SY | b14cd7e5-48ea-4f24-ac01-1635f43f3e03 | 8 |
| 353538 | isosorbide mononitrate 60 MG 24 HR Extended Release Oral Tablet | SY | b14cd7e5-48ea-4f24-ac01-1635f43f3e03 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50090-2554-0 | 50090255400 | 30 in 1 BOTTLE | Historical |
| 50090-2554-1 | 50090255401 | 100 in 1 BOTTLE | Historical |
| 50090-2554-2 | 50090255402 | 90 in 1 BOTTLE | Historical |