Isosorbide Mononitrate
- Product NDC
- 68071-3081
- 11-digit product format
- 680713081
- Labeler code
- 68071
- Product ID
- 68071-3081_bb12cdd1-6173-b57d-e053-2a95a90ac21e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Mononitrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA075522
- Marketing category
- ANDA
- Marketing start
- 2010-06-07
- 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
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-3081-3 | 2024-07-19 | C162847 | 48780-1 | ba0f9c33-12a8-a910-e053-dadaa90a0b85 | Isosorbide Mononitrate Extended-release Tablets, USP Rx only |
| 68071-3081-6 | 2024-07-19 | C162847 | 48780-1 | ba0f9c33-12a8-a910-e053-dadaa90a0b85 | Isosorbide Mononitrate Extended-release Tablets, USP Rx only |
| 68071-3081-9 | 2024-07-19 | C162847 | 48780-1 | ba0f9c33-12a8-a910-e053-dadaa90a0b85 | Isosorbide Mononitrate Extended-release Tablets, USP Rx only |
| 68071-3081-3 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-12a8-a910-e053-dadaa90a0b85 | Isosorbide Mononitrate Extended-release Tablets, USP Rx only |
| 68071-3081-6 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-12a8-a910-e053-dadaa90a0b85 | Isosorbide Mononitrate Extended-release Tablets, USP Rx only |
| 68071-3081-9 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-12a8-a910-e053-dadaa90a0b85 | Isosorbide Mononitrate Extended-release Tablets, USP Rx only |
| 68071-3081-3 | 2021-02-11 | C162847 | 48780-1 | ba0f9c33-12a8-a910-e053-dadaa90a0b85 | Isosorbide Mononitrate Extended-release Tablets, USP Rx only |
| 68071-3081-6 | 2021-02-11 | C162847 | 48780-1 | ba0f9c33-12a8-a910-e053-dadaa90a0b85 | Isosorbide Mononitrate Extended-release Tablets, USP Rx only |
| 68071-3081-9 | 2021-02-11 | C162847 | 48780-1 | ba0f9c33-12a8-a910-e053-dadaa90a0b85 | Isosorbide Mononitrate Extended-release Tablets, USP Rx only |
| 68071-3081-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-12a8-a910-e053-dadaa90a0b85 | Isosorbide Mononitrate Extended-release Tablets, USP Rx only |
| 68071-3081-6 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-12a8-a910-e053-dadaa90a0b85 | Isosorbide Mononitrate Extended-release Tablets, USP Rx only |
| 68071-3081-9 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-12a8-a910-e053-dadaa90a0b85 | Isosorbide Mononitrate Extended-release Tablets, USP Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3081-3 | Isosorbide Mononitrate | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 4 |
| 68071-3081-6 | Isosorbide Mononitrate | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 4 |
| 68071-3081-9 | Isosorbide Mononitrate | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3081 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NUCARE PHARMACEUTICALS, INC.] | 4 | Legacy NDC, 3 package rows | 20240720_4ab91ea4-3ddb-5fd3-e054-00144ff88e88.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 |
|---|
| 68071-3081-3 | 68071308103 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3081-3) | 2017-03-14 | 0000-00-00 | No | No | Current |
| 68071-3081-6 | 68071308106 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3081-6) | 2017-03-14 | 0000-00-00 | No | No | Current |
| 68071-3081-9 | 68071308109 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3081-9) | 2017-03-14 | 0000-00-00 | No | No | Current |