ISOSORBIDE MONONITRATE
- Product NDC
- 13668-106
- 11-digit product format
- 136680106
- Labeler code
- 13668
- Product ID
- 13668-106_34e0adcc-8899-4abb-bba4-6be95d0ce2dd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ISOSORBIDE MONONITRATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA200495
- Marketing category
- ANDA
- Marketing start
- 2011-06-03
- Substance
- ISOSORBIDE MONONITRATE
- Active strength
- 120 mg/1
- Pharmacologic classes
- Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LX1OH63030 |
| Rxcui | 311196, 317110, 353538 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13668-106-01 | ISOSORBIDE MONONITRATE | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 13 |
| 13668-106-10 | ISOSORBIDE MONONITRATE | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | | 13 |
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 [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| ISOSORBIDE MONONITRATE | ACTIVE MOIETY | LX1OH63030 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| DIETHYL PHTHALATE | INACTIVE INGREDIENT | UF064M00AF | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| HYDROGENATED CASTOR OIL | INACTIVE INGREDIENT | ZF94AP8MEY | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13668-106 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED] | 12 | Current NDC, Legacy NDC, 2 package rows | 20241025_0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c.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 |
|---|
| 13668-106-01 | 13668010601 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-106-01) | 2011-06-03 | 0000-00-00 | No | No | Current |
| 13668-106-05 | 13668010605 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-106-05) | 2011-06-03 | 0000-00-00 | No | No | Current |
| 13668-106-10 | 13668010610 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-106-10) | 2011-06-03 | 0000-00-00 | No | No | Current |
| 13668-106-59 | 13668010659 | 28 TABLET, EXTENDED RELEASE in 1 CARTON (13668-106-59) | 2011-06-03 | 0000-00-00 | No | No | Current |
| 13668-106-74 | 13668010674 | 100 TABLET, EXTENDED RELEASE in 1 CARTON (13668-106-74) | 2011-06-03 | 0000-00-00 | No | No | Current |