ISOSORBIDE MONONITRATE
- Product NDC
- 0615-7767
- 11-digit product format
- 006157767
- Labeler code
- 0615
- Product ID
- 0615-7767_c8f05814-88ec-44f5-bf13-52590d9f9052
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ISOSORBIDE MONONITRATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA200270
- Marketing category
- ANDA
- Marketing start
- 2011-06-03
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-7767-05 | ISOSORBIDE MONONITRATE | 15 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 15 | | 5 |
| 0615-7767-30 | ISOSORBIDE MONONITRATE | 5 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 5 | | 5 |
| 0615-7767-30 | ISOSORBIDE MONONITRATE | 6 in 1 BOX, UNIT-DOSE | TABLET, EXTENDED RELEASE | 6 | | 5 |
| 0615-7767-39 | ISOSORBIDE MONONITRATE | 30 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-7767 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 5 | Current NDC, Legacy NDC, 4 package rows | 20240815_63dc518f-4f86-4820-98c2-5de8aed09a4b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0615-7767-05 | 00615776705 | 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7767-05) | | 2022-02-02 | 0000-00-00 | No | No | Current |
| 0615-7767-30 | 00615776730 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-7767-30) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 6 blister pack | 2022-02-11 | 0000-00-00 | No | No | Current |
| 0615-7767-39 | 00615776739 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7767-39) | | 2022-02-02 | 0000-00-00 | No | No | Current |