What is NDC 71610-813?

71610-813 is the product NDC for cilostazol, Cilostazol 100 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

cilostazol NDC 71610-813 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-813Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0813Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
71610-813-26	7161008132671610081326	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
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077030
Marketing start: Apr 12, 2022
Listing expires: Dec 31, 2026
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

N471610081326 followed by a unit qualifier and the quantity

Package 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 Apr 4, 2024. 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.

Full label on DailyMed (opens in a new tab)

About NDC 71610-813

What is NDC 71610-813?: 71610-813 is the product NDC for cilostazol, Cilostazol 100 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other cilostazol NDCs
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 50 mg/1	TabletOral	direct rx	72189-116	72189-0116-60
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

All 16 cilostazol NDCs

Other NDCs under ANDA 077030

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 077030
Product	Strength	Form · route	Labeler	Product NDC
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
cilostazol	Cilostazol 50 mg/1	TabletOral	Apotex Corp.	60505-2521
cilostazol	Cilostazol 100 mg/1	TabletOral	Apotex Corp.	60505-2522
cilostazol	Cilostazol 100 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-822