NDC codes

FDA NDC Directory
Product NDC (as listed)50090-6562Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-6562Add 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
50090-6562-050090656200500906562001 BOTTLE in 1 CARTON (50090-6562-0) / 6.6 mL in 1 BOTTLEMarketed from Jul 18, 2023

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)
Ciclopirox
Generic name (nonproprietary)
ciclopirox
Active ingredients
Ciclopirox — 80 mg/mL
Dosage form
Solution
Route
Topical
Labeler
A-S Medication SolutionsNDC labeler code 50090
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078172
Marketing start
Listing expires
Other FDA classes
Decreased DNA Replication (Physiologic effect)Decreased Protein Synthesis (Physiologic effect)Decreased RNA Replication (Physiologic effect)Protein Synthesis Inhibitors (Mechanism)
Identifiers
Product ID 50090-6562_68e187e9-f915-4585-bfcc-c78fb13cd75fSPL ID 68e187e9-f915-4585-bfcc-c78fb13cd75fSPL set ID b281493f-ce8c-42f8-95c7-2eb1c9712157RxCUI 309291UNII 19W019ZDRJ

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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450090656200 followed by a unit qualifier and the quantity

Package 50090-6562-00. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE (To understand fully the indication for this product, please read the entire INDICATION AND USAGE section of the labeling.) Ciclopirox topical solution, USP 8% as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum . The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures. No studies have been conduc…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50090-6562

What is NDC 50090-6562?
50090-6562 is the product NDC for Ciclopirox, Ciclopirox 80 mg/mL solution, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ciclopirox.
What is the active ingredient?
Ciclopirox.
Who is the labeler?
A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ciclopirox?
23 other product NDCs are listed under this name. See all Ciclopirox 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 Ciclopirox NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CiclopiroxCiclopirox 1 g/100mLShampooTopicalEncube Ethicals, Inc.21922-10521922-0105-52
CiclopiroxCiclopirox 80 mg/mLSolutionTopicalPreferred Pharmaceuticals Inc.68788-875568788-8755-06
CiclopiroxCiclopirox 80 mg/mLSolutionTopicalEncube Ethicals, Inc.21922-05321922-0053-51
CiclopiroxCiclopirox 80 mg/mLSolutionTopicalBryant Ranch Prepack71335-283671335-2836-01
CiclopiroxCiclopirox 80 mg/mLSolutionTopicalBryant Ranch Prepack72162-229872162-2298-02
CiclopiroxCiclopirox 80 mg/mLSolutionTopicalAcella Pharmaceuticals, LLC42192-71542192-0715-06
CiclopiroxCiclopirox 80 mg/mLSolutionTopicalBryant Ranch Prepack72162-132172162-1321-02
CiclopiroxCiclopirox 80 mg/mLSolutionTopicalPreferred Pharmaceuticals, Inc.68788-679768788-6797-06
CiclopiroxCiclopirox 10 mg/.96mLShampooTopicalActavis Pharma, Inc.0591-215900591-2159-90
ciclopiroxCiclopirox 7.7 mg/gGelTopicalGlenmark Pharmaceuticals Inc., USA68462-45568462-0455-3568462-0455-4768462-0455-94

All 24 Ciclopirox NDCs

Other NDCs under ANDA 078172

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

FDA NDC Directory listings under ANDA 078172
ProductStrengthForm · routeLabelerProduct NDC
CiclopiroxCiclopirox 80 mg/mLSolutionTopicalAcella Pharmaceuticals, LLC42192-715
CiclopiroxCiclopirox 80 mg/mLSolutionTopicalBryant Ranch Prepack72162-1321

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