Isosorbide Mononitrate
- Product NDC
- 71335-0431
- 11-digit product format
- 713350431
- Labeler code
- 71335
- Product ID
- 71335-0431_9295dcaa-f35a-4f73-82bd-da3fb6ea773e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Mononitrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71335-0431-1 | 2021-04-28 | C162847 | 48780-1 | 9d75b9d0-68a4-f424-e053-dadaa90a57ce | 6e3b4e84-bcc1-4be5-80c2-075180800145 |
| 71335-0431-2 | 2021-04-28 | C162847 | 48780-1 | 9d75b9d0-68a4-f424-e053-dadaa90a57ce | 6e3b4e84-bcc1-4be5-80c2-075180800145 |
| 71335-0431-3 | 2021-04-28 | C162847 | 48780-1 | 9d75b9d0-68a4-f424-e053-dadaa90a57ce | 6e3b4e84-bcc1-4be5-80c2-075180800145 |
| 71335-0431-4 | 2021-04-28 | C162847 | 48780-1 | 9d75b9d0-68a4-f424-e053-dadaa90a57ce | 6e3b4e84-bcc1-4be5-80c2-075180800145 |
| 71335-0431-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-68a4-f424-e053-dadaa90a57ce | 6e3b4e84-bcc1-4be5-80c2-075180800145 |
| 71335-0431-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-68a4-f424-e053-dadaa90a57ce | 6e3b4e84-bcc1-4be5-80c2-075180800145 |
| 71335-0431-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-68a4-f424-e053-dadaa90a57ce | 6e3b4e84-bcc1-4be5-80c2-075180800145 |
| 71335-0431-4 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-68a4-f424-e053-dadaa90a57ce | 6e3b4e84-bcc1-4be5-80c2-075180800145 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71335-0431-1 | EA - Each | 71335-0431 | 5a4a414c-cb69-42cb-b319-67e25826404f | 1 | 2018-03-08 |
| 71335-0431-2 | EA - Each | 71335-0431 | 093d6007-bf97-4e5e-8438-8565299b204b | 1 | 2018-03-08 |
| 71335-0431-3 | EA - Each | 71335-0431 | 3685e77f-7185-4bed-8e16-38c638eed020 | 1 | 2018-03-08 |
| 71335-0431-4 | EA - Each | 71335-0431 | d469cccb-3c4c-4760-9b88-b34d96e258a2 | 1 | 2018-03-08 |