Isosorbide Mononitrate
- Product NDC
- 70518-3585
- 11-digit product format
- 705183585
- Labeler code
- 70518
- Product ID
- 70518-3585_eff438a8-f3b8-78a0-e053-2a95a90ab086
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Mononitrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA210918
- Marketing category
- ANDA
- Marketing start
- 2022-12-05
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3585 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.] | 3 | Legacy NDC | 20240116_7c5baffb-885f-4dcf-8964-7f8ac91798b1.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3585-0 | 70518358500 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-3585-0) | 2022-12-05 | 0000-00-00 | No | No | Current |