ISOSORBIDE MONONITRATE
- Product NDC
- 0904-6449
- 11-digit product format
- 009046449
- Labeler code
- 0904
- Product ID
- 0904-6449_af7ec13d-7e9f-4407-9588-f61a75bac043
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ISOSORBIDE MONONITRATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA200270
- Marketing category
- ANDA
- Marketing start
- 2015-01-05
- 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISOSORBIDE MONONITRATE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LX1OH63030 |
| Rxcui | 317110, 353538 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-6449-61 | ISOSORBIDE MONONITRATE | 1 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 1 | | 8 |
| 0904-6449-61 | ISOSORBIDE MONONITRATE | 100 in 1 CARTON | TABLET, EXTENDED RELEASE | 100 | | 8 |
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 [MAJOR PHARMACEUTICALS] | 3 | |
| ISOSORBIDE MONONITRATE | ACTIVE MOIETY | LX1OH63030 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 3 | |
| DIETHYL PHTHALATE | INACTIVE INGREDIENT | UF064M00AF | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 3 | |
| HYDROGENATED CASTOR OIL | INACTIVE INGREDIENT | ZF94AP8MEY | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 3 | |
| HYDROXYPROPYL CELLULOSE (TYPE E) | INACTIVE INGREDIENT | 66O7AQV0RT | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 3 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6449 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250205_8cbb364a-bafe-454b-a53f-bd7cd69a5593.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 |
|---|
| 0904-6449-61 | 00904644961 | 100 BLISTER PACK in 1 CARTON (0904-6449-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 100 blister pack | 2015-01-05 | 0000-00-00 | No | No | Current |