NDC codes

FDA NDC Directory
Product NDC (as listed)71610-822Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71610-0822Add 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 NDC11-digit (billing)PackageCopy
71610-822-2671610082226716100822261200 TABLET in 1 BOTTLE (71610-822-26)Marketed from Apr 12, 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
Listing expires
Other FDA classes
Phosphodiesterase 3 Inhibitors (Mechanism)
Identifiers
Product ID 71610-822_15ead24d-7d6b-b7ad-e063-6294a90ab1bbSPL ID 15ead24d-7d6b-b7ad-e063-6294a90ab1bbSPL set ID 15ead884-bd4f-7f4b-e063-6394a90a8f81RxCUI 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

N471610082226 followed by a unit qualifier and the quantity

Package 71610-0822-26. 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.

Full label on DailyMed (opens in a new tab)

About NDC 71610-822

What is NDC 71610-822?
71610-822 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
cilostazolCilostazol 100 mg/1TabletOralAvKARE42291-45342291-0453-60
cilostazolCilostazol 100 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-81371610-0813-26
CilostazolCilostazol 50 mg/1TabletOraldirect rx72189-11672189-0116-60
CilostazolCilostazol 50 mg/1TabletOralSlate Run Pharmaceuticals, LLC70436-15670436-0156-06
CilostazolCilostazol 100 mg/1TabletOralSlate Run Pharmaceuticals, LLC70436-15770436-0157-06
cilostazolCilostazol 50 mg/1TabletOralAvPAK50268-17650268-0176-15
cilostazolCilostazol 100 mg/1TabletOralAvPAK50268-17750268-0177-15
CilostazolCilostazol 100 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0093-206400093-2064-0600093-2064-50
CilostazolCilostazol 100 mg/1TabletOralBryant Ranch Prepack63629-879563629-8795-01
CilostazolCilostazol 50 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0093-206500093-2065-06

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
ProductStrengthForm · routeLabelerProduct NDC
cilostazolCilostazol 100 mg/1TabletOralAvKARE42291-453
cilostazolCilostazol 50 mg/1TabletOralAvPAK50268-176
cilostazolCilostazol 100 mg/1TabletOralAvPAK50268-177
cilostazolCilostazol 50 mg/1TabletOralApotex Corp.60505-2521
cilostazolCilostazol 100 mg/1TabletOralApotex Corp.60505-2522
cilostazolCilostazol 100 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-813

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