Isosorbide Mononitrate
- Product NDC
- 53002-1570
- 11-digit product format
- 530021570
- Labeler code
- 53002
- Product ID
- 53002-1570_24d88976-1196-4818-8c89-5584d85f4609
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Mononitrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA075522
- Marketing category
- ANDA
- Marketing start
- 2017-01-05
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-1570-3 | Isosorbide Mononitrate | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-1570 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 1 package rows | 20230609_dca5ffde-4b95-4f47-b368-c1ad04ec27b7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-1570-3 | 53002157003 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (53002-1570-3) | 2018-10-01 | 0000-00-00 | No | No | Current |