Prescription drug · ANDA
Cilostazol NDC 72189-116
Cilostazol 50 mg/1 · Tablet · Oral · direct rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-116-60 | 7218901166072189011660 | 60 TABLET in 1 BOTTLE (72189-116-60)Marketed from Dec 2, 2020 |
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 — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- direct rxNDC labeler code 72189
- 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 72189-116_2be8fd92-0c90-d751-e063-6394a90af165SPL ID 2be8fd92-0c90-d751-e063-6394a90af165SPL set ID b57d3c1e-e36f-5255-e053-2a95a90ada83RxCUI 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
N472189011660followed by a unit qualifier and the quantityPackage 72189-0116-60. 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.
Excerpt only. Read the full label for complete information.
About NDC 72189-116
- What is NDC 72189-116?
- 72189-116 is the product NDC for Cilostazol, Cilostazol 50 mg/1 tablet, listed with the FDA by direct rx. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cilostazol.
- What is the active ingredient?
- Cilostazol.
- Who is the labeler?
- direct rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cilostazol?
- 15 other product NDCs are listed under this name. See all Cilostazol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cilostazol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| cilostazol | Cilostazol 100 mg/1 | TabletOral | AvKARE | 42291-453 | 42291-0453-60 |
| cilostazol | Cilostazol 100 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-813 | 71610-0813-26 |
| Cilostazol | Cilostazol 50 mg/1 | TabletOral | Slate Run Pharmaceuticals, LLC | 70436-156 | 70436-0156-06 |
| Cilostazol | Cilostazol 100 mg/1 | TabletOral | Slate Run Pharmaceuticals, LLC | 70436-157 | 70436-0157-06 |
| cilostazol | Cilostazol 50 mg/1 | TabletOral | AvPAK | 50268-176 | 50268-0176-15 |
| cilostazol | Cilostazol 100 mg/1 | TabletOral | AvPAK | 50268-177 | 50268-0177-15 |
| Cilostazol | Cilostazol 100 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-2064 | 00093-2064-0600093-2064-50 |
| Cilostazol | Cilostazol 100 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8795 | 63629-8795-01 |
| Cilostazol | Cilostazol 50 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-2065 | 00093-2065-06 |
| Cilostazol | Cilostazol 50 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8796 | 63629-8796-01 |
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 | Teva Pharmaceuticals USA, Inc. | 0093-2064 |
| Cilostazol | Cilostazol 50 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-2065 |
| Cilostazol | Cilostazol 100 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8795 |
| Cilostazol | Cilostazol 50 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8796 |