Isosorbide Mononitrate
- Product NDC
- 23155-519
- 11-digit product format
- 231550519
- Labeler code
- 23155
- Product ID
- 23155-519_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
- 2017-01-05
- Marketing end
- 0000-00-00
- Substance
- ISOSORBIDE MONONITRATE
- Active strength
- 30 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 |
|---|---|---|---|---|---|
| 23155-519-01 | EA - Each | 23155-519 | 28c4e9ef-87fb-428f-b4b4-c4fccbc5e9af | 1 | 2017-03-06 |
| 23155-519-05 | EA - Each | 23155-519 | 4cc54f30-327a-41af-9af2-9a4b7566af35 | 1 | 2017-03-06 |
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 |
|---|---|---|---|---|
| 317110 | isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet | PSN | 00270f4b-53e4-482b-9f99-aee57ace7831 | 5 |
| 317110 | isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet | PSN | 65935a15-a023-1941-e053-2991aa0a5eb4 | 5 |
| 317110 | isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet | PSN | dca5ffde-4b95-4f47-b368-c1ad04ec27b7 | 5 |
| 317110 | 24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet | SCD | 00270f4b-53e4-482b-9f99-aee57ace7831 | 5 |
| 317110 | 24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet | SCD | 65935a15-a023-1941-e053-2991aa0a5eb4 | 5 |
| 317110 | 24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet | SCD | dca5ffde-4b95-4f47-b368-c1ad04ec27b7 | 5 |
| 317110 | isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet | SY | 00270f4b-53e4-482b-9f99-aee57ace7831 | 5 |
| 317110 | isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet | SY | 65935a15-a023-1941-e053-2991aa0a5eb4 | 5 |
| 317110 | isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet | SY | dca5ffde-4b95-4f47-b368-c1ad04ec27b7 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 23155-519-01 | 23155051901 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-519-01) | 2017-01-05 | 0000-00-00 | No | No | Current |
| 23155-519-03 | 23155051903 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-519-03) | 2017-01-05 | 0000-00-00 | No | No | Current |
| 23155-519-05 | 23155051905 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-519-05) | 2017-01-05 | 0000-00-00 | No | No | Current |