Isosorbide Mononitrate
- Product NDC
- 0615-4544
- 11-digit product format
- 006154544
- Labeler code
- 0615
- Product ID
- 0615-4544_80c1d483-2717-4090-a8ac-a2f9c85fbc5f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide mononitrate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, Inc dba Vangard Labs
- Application
- ANDA076813
- Marketing category
- ANDA
- Marketing start
- 2006-03-30
- 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
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0615-4544-05 | 2021-06-29 | C162847 | 48780-1 | 9d75b9d0-67d5-f424-e053-dadaa90a57ce | 7345c065-3627-4fb2-8470-7e80d450b38e |
| 0615-4544-31 | 2021-06-29 | C162847 | 48780-1 | 9d75b9d0-67d5-f424-e053-dadaa90a57ce | 7345c065-3627-4fb2-8470-7e80d450b38e |
| 0615-4544-39 | 2021-06-29 | C162847 | 48780-1 | 9d75b9d0-67d5-f424-e053-dadaa90a57ce | 7345c065-3627-4fb2-8470-7e80d450b38e |
| 0615-4544-05 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-67d5-f424-e053-dadaa90a57ce | 7345c065-3627-4fb2-8470-7e80d450b38e |
| 0615-4544-31 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-67d5-f424-e053-dadaa90a57ce | 7345c065-3627-4fb2-8470-7e80d450b38e |
| 0615-4544-39 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-67d5-f424-e053-dadaa90a57ce | 7345c065-3627-4fb2-8470-7e80d450b38e |