ISOSORBIDE MONONITRATE
- Product NDC
- 0615-7768
- 11-digit product format
- 006157768
- Labeler code
- 0615
- Product ID
- 0615-7768_4beb800d-fb92-42eb-a765-50ed0dfe1587
- 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
- ANDA200495
- Marketing category
- ANDA
- Marketing start
- 2011-06-03
- Substance
- ISOSORBIDE MONONITRATE
- Active strength
- 60 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 | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LX1OH63030 |
| Rxcui | 353538 |
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 |
|---|
| 0615-7768-05 | ISOSORBIDE MONONITRATE | 15 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 15 | | 12 |
| 0615-7768-39 | ISOSORBIDE MONONITRATE | 30 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 30 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ISOSORBIDE MONONITRATE | ACTIVE INGREDIENT | LX1OH63030 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| ISOSORBIDE MONONITRATE | ACTIVE MOIETY | LX1OH63030 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| DIETHYL PHTHALATE | INACTIVE INGREDIENT | UF064M00AF | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| HYDROGENATED CASTOR OIL | INACTIVE INGREDIENT | ZF94AP8MEY | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-7768 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240815_ba6120c8-c885-4cfa-b68e-9eee7a3bad6d.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 |
|---|
| 0615-7768-05 | 00615776805 | 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7768-05) | 2022-02-03 | 0000-00-00 | No | No | Current |
| 0615-7768-39 | 00615776839 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7768-39) | 2022-02-03 | 0000-00-00 | No | No | Current |