Prescription drug · ANDA
Cilostazol NDC 63629-8796
Cilostazol 50 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8796-1 | 63629879601 | 60 TABLET in 1 BOTTLE (63629-8796-1)Marketed from Aug 30, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077027
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 3 Inhibitors (Mechanism)
- Identifiers
- Product ID 63629-8796_27535865-53dd-4cd0-b428-8901daac6c52SPL ID 27535865-53dd-4cd0-b428-8901daac6c52SPL set ID f728395c-684c-4087-a389-c323dbcb72ddRxCUI 242462UNII 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
N463629879601followed by a unit qualifier and the quantityPackage 63629-8796-01. 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
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 tablets are 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 077027
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 | Bryant Ranch Prepack | 63629-8795 |
| Cilostazol | Cilostazol 50 mg/1 | TabletOral | direct rx | 72189-116 |
| Cilostazol | Cilostazol 100 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-2064 |
| Cilostazol | Cilostazol 50 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-2065 |