Isosorbide Mononitrate
- Product NDC
- 68071-4290
- 11-digit product format
- 680714290
- Labeler code
- 68071
- Product ID
- 68071-4290_1a3dc619-6b11-21b4-e063-6294a90acb1e
- 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
- 2017-01-05
- Substance
- ISOSORBIDE MONONITRATE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Isosorbide Mononitrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISOSORBIDE MONONITRATE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LX1OH63030 |
| Rxcui | 317110 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-4290-3 | 2024-06-06 | C162847 | 48780-1 | ba0f9c33-59f1-a910-e053-dadaa90a0b85 | Isosorbide Mononitrate Extended-release Tablets, USP Rx only |
| 68071-4290-6 | 2024-06-06 | C162847 | 48780-1 | ba0f9c33-59f1-a910-e053-dadaa90a0b85 | Isosorbide Mononitrate Extended-release Tablets, USP Rx only |
| 68071-4290-9 | 2024-06-06 | C162847 | 48780-1 | ba0f9c33-59f1-a910-e053-dadaa90a0b85 | Isosorbide Mononitrate Extended-release Tablets, USP Rx only |
| 68071-4290-3 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-59f1-a910-e053-dadaa90a0b85 | Isosorbide Mononitrate Extended-release Tablets, USP Rx only |
| 68071-4290-6 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-59f1-a910-e053-dadaa90a0b85 | Isosorbide Mononitrate Extended-release Tablets, USP Rx only |
| 68071-4290-9 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-59f1-a910-e053-dadaa90a0b85 | Isosorbide Mononitrate Extended-release Tablets, USP Rx only |
| 68071-4290-3 | 2021-02-16 | C162847 | 48780-1 | ba0f9c33-59f1-a910-e053-dadaa90a0b85 | Isosorbide Mononitrate Extended-release Tablets, USP Rx only |
| 68071-4290-6 | 2021-02-16 | C162847 | 48780-1 | ba0f9c33-59f1-a910-e053-dadaa90a0b85 | Isosorbide Mononitrate Extended-release Tablets, USP Rx only |
| 68071-4290-9 | 2021-02-16 | C162847 | 48780-1 | ba0f9c33-59f1-a910-e053-dadaa90a0b85 | Isosorbide Mononitrate Extended-release Tablets, USP Rx only |
| 68071-4290-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-59f1-a910-e053-dadaa90a0b85 | Isosorbide Mononitrate Extended-release Tablets, USP Rx only |
| 68071-4290-6 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-59f1-a910-e053-dadaa90a0b85 | Isosorbide Mononitrate Extended-release Tablets, USP Rx only |
| 68071-4290-9 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-59f1-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 |
|---|
| 68071-4290-3 | Isosorbide Mononitrate | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 5 |
| 68071-4290-6 | Isosorbide Mononitrate | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 5 |
| 68071-4290-9 | Isosorbide Mononitrate | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4290 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NUCARE PHARMACEUTICALS,INC.] | 5 | Current NDC, Legacy NDC, 3 package rows | 20240608_65935a15-a023-1941-e053-2991aa0a5eb4.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 |
|---|
| 68071-4290-3 | 68071429003 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-4290-3) | 2018-02-19 | 0000-00-00 | No | No | Current |
| 68071-4290-6 | 68071429006 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-4290-6) | 2018-02-19 | 0000-00-00 | No | No | Current |
| 68071-4290-9 | 68071429009 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-4290-9) | 2018-02-19 | 0000-00-00 | No | No | Current |