Prescription drug · ANDA
Isosorbide Dinitrate NDC 0615-8463
Isosorbide dinitrate 10 mg/1 · Tablet · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8463-39 | 00615846339 | 30 TABLET in 1 BLISTER PACK (0615-8463-39)Marketed from May 2, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Isosorbide Dinitrate
- Generic name (nonproprietary)
- isosorbide dinitrate
- Active ingredients
- Isosorbide dinitrate — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215723
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 0615-8463_e52655b8-2c52-4534-9f86-bb70ebff3321SPL ID e52655b8-2c52-4534-9f86-bb70ebff3321SPL set ID 74a7f767-fa2f-4640-be24-34a8a9128217RxCUI 197839, 206842, 381056UNII IA7306519N
- Pharmacologic class
- Nitrate Vasodilator
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400615846339followed by a unit qualifier and the quantityPackage 00615-8463-39. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215723
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Isosorbide Dinitrate | Isosorbide dinitrate 10 mg/1 | TabletOral | Proficient Rx LP | 82804-117 |
| Isosorbide Dinitrate | Isosorbide dinitrate 5 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-081 |
| Isosorbide Dinitrate | Isosorbide dinitrate 40 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-085 |
| Isosorbide Dinitrate | Isosorbide dinitrate 10 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-082 |
| Isosorbide Dinitrate | Isosorbide dinitrate 20 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-083 |
| Isosorbide Dinitrate | Isosorbide dinitrate 30 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-084 |
| Isosorbide Dinitrate | Isosorbide dinitrate 20 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8464 |
| Isosorbide Dinitrate | Isosorbide dinitrate 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4405 |
| Isosorbide Dinitrate | Isosorbide dinitrate 30 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8465 |
| Isosorbide Dinitrate | Isosorbide dinitrate 20 mg/1 | TabletOral | Proficient Rx LP | 82804-108 |