Isosorbide Dinitrate
- Product NDC
- 68151-2475
- 11-digit product format
- 681512475
- Labeler code
- 68151
- Product ID
- 68151-2475_56836c7b-981f-46e1-ba5c-8d0016a256c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Dinitrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Carilion Materials Management
- Application
- ANDA086067
- Marketing category
- ANDA
- Marketing start
- 1978-12-01
- Marketing end
- 0000-00-00
- Substance
- ISOSORBIDE DINITRATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e9ed2ee5-d109-4795-bffe-c3b047717749 | Product name | 2 | 20250107 |
| 1ee44c84-1ad7-16b4-788d-a549f91b0f44 | Product name | 4 | 20230316 |
| 0dcc68a5-df0d-b1a6-ba71-3da99d94ffe9 | Product name | 1 | 20140508 |
| b0c258c1-3fb1-4785-4031-5c4417fb7ecd | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68151-2475-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4738-f424-e053-dadaa90a57ce | ISOSORBIDE DINITRATE TABLETS, USP (Oral) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68151-2475-0 | Isosorbide Dinitrate | 1 in 1 PACKAGE | TABLET | 1 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ISOSORBIDE DINITRATE | ACTIVE INGREDIENT | IA7306519N | ISOSORBIDE DINITRATE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| ISOSORBIDE DINITRATE | ACTIVE MOIETY | IA7306519N | ISOSORBIDE DINITRATE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| AMMONIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | 10LGE70FSU | ISOSORBIDE DINITRATE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | ISOSORBIDE DINITRATE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ISOSORBIDE DINITRATE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ISOSORBIDE DINITRATE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ISOSORBIDE DINITRATE TABLET [CARILION MATERIALS MANAGEMENT] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68151-2475 | ISOSORBIDE DINITRATE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | Legacy NDC, 1 package rows | 20140708_9e806b87-e67f-4f01-9c22-3b53f9622b34.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314055 | isosorbide dinitrate 5 MG Oral Tablet | PSN | 9e806b87-e67f-4f01-9c22-3b53f9622b34 | 2 |
| 314055 | isosorbide dinitrate 5 MG Oral Tablet | SCD | 9e806b87-e67f-4f01-9c22-3b53f9622b34 | 2 |
| 314055 | ISDN 5 MG Oral Tablet | SY | 9e806b87-e67f-4f01-9c22-3b53f9622b34 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 68151-2475-0 | 68151247500 | 1 in 1 PACKAGE | Historical |