Isosorbide Mononitrate
- Product NDC
- 0603-4110
- 11-digit product format
- 006034110
- Labeler code
- 0603
- Product ID
- 0603-4110_4a86d677-edfd-4901-b857-d0b6a92c170e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Mononitrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Par Pharmaceutical
- Application
- ANDA090598
- Marketing category
- ANDA
- Marketing start
- 2010-08-11
- Marketing end
- 2019-10-31
- Substance
- ISOSORBIDE MONONITRATE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0603-4110-21 | EA - Each | 0603-4110 | f05c567c-65c8-4f87-a2cb-b843b0957706 | 1 | 2012-07-24 |
| 0603-4110-28 | EA - Each | 0603-4110 | 3920ec14-a6d1-48a0-ac75-df6b65568564 | 1 | 2012-07-24 |
| 0603-4110-32 | EA - Each | 0603-4110 | 99081510-2b62-4549-a661-c07328bdb4f0 | 1 | 2012-07-24 |
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 |