Prescription drug · ANDA
cilostazol NDC 71610-813
Cilostazol 100 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-813-26 | 71610081326 | 1200 TABLET in 1 BOTTLE (71610-813-26)Marketed from Apr 3, 2024 |
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)
- cilostazol
- Generic name (nonproprietary)
- cilostazol
- Active ingredients
- Cilostazol — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077030
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 3 Inhibitors (Mechanism)
- Identifiers
- Product ID 71610-813_1547a408-12a9-fadd-e063-6394a90a4ce0SPL ID 1547a408-12a9-fadd-e063-6394a90a4ce0SPL set ID 15478d90-312f-014e-e063-6294a90ae838RxCUI 242461UNII N7Z035406B
- Pharmacologic class
- Phosphodiesterase 3 Inhibitor
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
N471610081326followed by a unit qualifier and the quantityPackage 71610-0813-26. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance. Cilostazol is a phosphodiesterase III inhibitor (PDE III inhibitor) indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077030
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 |
|---|---|---|---|---|
| cilostazol | Cilostazol 100 mg/1 | TabletOral | Apotex Corp. | 60505-2522 |
| cilostazol | Cilostazol 50 mg/1 | TabletOral | Apotex Corp. | 60505-2521 |
| cilostazol | Cilostazol 100 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-822 |
| cilostazol | Cilostazol 100 mg/1 | TabletOral | AvKARE | 42291-453 |
| cilostazol | Cilostazol 50 mg/1 | TabletOral | AvPAK | 50268-176 |
| cilostazol | Cilostazol 100 mg/1 | TabletOral | AvPAK | 50268-177 |