Isosorbide Mononitrate
- Product NDC
- 70518-2122
- 11-digit product format
- 705182122
- Labeler code
- 70518
- Product ID
- 70518-2122_eadb8cf2-6ddd-4e78-e053-2995a90aff14
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Mononitrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA075522
- Marketing category
- ANDA
- Marketing start
- 2019-05-29
- 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 |
|---|
| 70518-2122 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.] | 13 | Legacy NDC | 20250308_3c3699d1-b012-438b-8027-986962e318ac.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-2122-0 | 70518212200 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-2122-0) | 2019-05-29 | 0000-00-00 | No | No | Current |
| 70518-2122-1 | 70518212201 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2122-1) | 2019-07-10 | 0000-00-00 | No | No | Current |