Prescription drug · ANDA
Isosorbide Dinitrate NDC 68084-082
Isosorbide dinitrate 10 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68084-082-01 | 68084008201 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-082-01) / 1 TABLET in 1 BLISTER PACK (68084-082-11)Marketed from Oct 21, 2013 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- Labeler
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 086925
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 68084-082_4133d711-2ce0-0891-e063-6294a90aeaabSPL ID 4133d711-2ce0-0891-e063-6294a90aeaabSPL set ID 5c94ecc0-fcaa-4af3-82c2-ff124f2df3e1RxCUI 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
N468084008201followed by a unit qualifier and the quantityPackage 68084-0082-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 086925
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 | AvPAK | 50268-448 |
| Isosorbide Dinitrate | Isosorbide dinitrate 10 mg/1 | TabletOral | Par Health USA, LLC | 49884-021 |