ISOSORBIDE MONONITRATE
- Product NDC
- 10544-243
- 11-digit product format
- 105440243
- Labeler code
- 10544
- Product ID
- 10544-243_364aab7b-d1f8-4cb1-ad8d-163dcf723c6e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ISOSORBIDE MONONITRATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA200495
- Marketing category
- ANDA
- Marketing start
- 2013-11-15
- Marketing end
- 0000-00-00
- Substance
- ISOSORBIDE MONONITRATE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 10544-243-30 | ISOSORBIDE MONONITRATE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 1 |
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 [BLENHEIM PHARMACAL, INC.] | 1 | |
| ISOSORBIDE MONONITRATE | ACTIVE MOIETY | LX1OH63030 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 1 | |
| DIETHYL PHTHALATE | INACTIVE INGREDIENT | UF064M00AF | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 1 | |
| HYDROGENATED CASTOR OIL | INACTIVE INGREDIENT | ZF94AP8MEY | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 1 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-243 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.] | 1 | Legacy NDC, 1 package rows | 20150317_364aab7b-d1f8-4cb1-ad8d-163dcf723c6e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-243-30 | 10544024330 | 30 in 1 BOTTLE | Historical |