Isosorbide Mononitrate
- Product NDC
- 23155-178
- 11-digit product format
- 231550178
- Labeler code
- 23155
- Product ID
- 23155-178_649023db-b51a-4696-ae92-28c926efc2d6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Mononitrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Application
- ANDA075522
- Marketing category
- ANDA
- Marketing start
- 2010-06-07
- 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
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cc3f7505-fd5d-aab9-1128-173349f98a63 | Product name | 4 | 20230113 |
| f23201a1-1f10-4748-0041-3c03fbb37cfb | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 23155-178-01 | EA - Each | 23155-178 | ef44f0f6-bd4e-47c0-a9c5-cce35136648e | 1 | 2012-07-24 |
| 23155-178-05 | EA - Each | 23155-178 | 14d7c2cd-47cb-4f0d-995f-5f36e1a6a7b6 | 1 | 2017-05-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ISOSORBIDE MONONITRATE | ACTIVE INGREDIENT | LX1OH63030 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.] | 4 | |
| ISOSORBIDE MONONITRATE | ACTIVE MOIETY | LX1OH63030 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.] | 4 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.] | 4 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC.] | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 353538 | isosorbide mononitrate 60 MG 24HR Extended Release Oral Tablet | PSN | 4ab91ea4-3ddb-5fd3-e054-00144ff88e88 | 4 |
| 353538 | 24 HR isosorbide mononitrate 60 MG Extended Release Oral Tablet | SCD | 4ab91ea4-3ddb-5fd3-e054-00144ff88e88 | 4 |
| 353538 | isosorbide mononitrate 60 MG 24 HR Extended Release Oral Tablet | SY | 4ab91ea4-3ddb-5fd3-e054-00144ff88e88 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 23155-178-01 | 23155017801 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-178-01) | 2010-06-07 | 0000-00-00 | No | No | Current |
| 23155-178-05 | 23155017805 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-178-05) | 2010-06-07 | 0000-00-00 | No | No | Current |
| 23155-178-09 | 23155017809 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-178-09) | 2010-06-07 | 0000-00-00 | No | No | Current |