Prescription drug · ANDA
Isosorbide Dinitrate NDC 50268-447
Isosorbide dinitrate 5 mg/1 · Tablet · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-447-15 | 50268044715 | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-447-15) / 1 TABLET in 1 BLISTER PACK (50268-447-11)Marketed from Sep 13, 2016 |
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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- AvPAK
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 086923
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 50268-447_4a7f77ca-73e0-4162-e063-6294a90a1418SPL ID 4a7f77ca-73e0-4162-e063-6294a90a1418SPL set ID 0e5842f2-74f6-1f02-01bc-07578bd3b393RxCUI 206842, 314055, 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
N450268044715followed by a unit qualifier and the quantityPackage 50268-0447-15. 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 086923
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 5 mg/1 | TabletOral | Par Health USA, LLC | 49884-020 |