What is NDC 0574-2061?

0574-2061 is the product NDC for Ciclopirox, Ciclopirox 7.7 mg/g gel, listed with the FDA by Padagis US LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Padagis US LLC, NDC labeler code 0574. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ciclopirox NDC 0574-2061 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0574-2061Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00574-2061Add 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
0574-2061-01	0057420610100574206101	1 TUBE in 1 CARTON (0574-2061-01) / 100 g in 1 TUBEMarketed from Jan 7, 2009
0574-2061-30	0057420613000574206130	1 TUBE in 1 CARTON (0574-2061-30) / 30 g in 1 TUBEMarketed from Jan 7, 2009
0574-2061-45	0057420614500574206145	1 TUBE in 1 CARTON (0574-2061-45) / 45 g in 1 TUBEMarketed from Jan 7, 2009

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Ciclopirox
Generic name (nonproprietary): ciclopirox
Active ingredients: Ciclopirox — 7.7 mg/g
Dosage form: Gel
Route: Topical
Labeler: Padagis US LLCNDC labeler code 0574
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078266
Marketing start: Jan 7, 2009
Listing expires: Dec 31, 2026
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 0574-2061_04609ea1-41be-4aa6-ad71-7424db6ae548SPL ID 04609ea1-41be-4aa6-ad71-7424db6ae548SPL set ID b6a02568-867b-4c7b-890f-5d28bf0b363dRxCUI 313941UNII 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

N400574206101 followed by a unit qualifier and the quantity

Package 00574-2061-01. 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 Nov 1, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Superficial Dermatophyte Infections Ciclopirox Gel, 0.77% is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum . Seborrheic Dermatitis Ciclopirox Gel, 0.77% is indicated for the topical treatment of seborrheic dermatitis of the scalp.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0574-2061

What is NDC 0574-2061?: 0574-2061 is the product NDC for Ciclopirox, Ciclopirox 7.7 mg/g gel, listed with the FDA by Padagis US LLC. It has 3 package NDCs, 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?: Padagis US LLC, NDC labeler code 0574. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ciclopirox	Ciclopirox 1 g/100mL	ShampooTopical	Encube Ethicals, Inc.	21922-105	21922-0105-52
Ciclopirox	Ciclopirox 80 mg/mL	SolutionTopical	Preferred Pharmaceuticals Inc.	68788-8755	68788-8755-06
Ciclopirox	Ciclopirox 80 mg/mL	SolutionTopical	Encube Ethicals, Inc.	21922-053	21922-0053-51
Ciclopirox	Ciclopirox 80 mg/mL	SolutionTopical	Bryant Ranch Prepack	71335-2836	71335-2836-01
Ciclopirox	Ciclopirox 80 mg/mL	SolutionTopical	Bryant Ranch Prepack	72162-2298	72162-2298-02
Ciclopirox	Ciclopirox 80 mg/mL	SolutionTopical	Acella Pharmaceuticals, LLC	42192-715	42192-0715-06
Ciclopirox	Ciclopirox 80 mg/mL	SolutionTopical	A-S Medication Solutions	50090-6562	50090-6562-00
Ciclopirox	Ciclopirox 80 mg/mL	SolutionTopical	Bryant Ranch Prepack	72162-1321	72162-1321-02
Ciclopirox	Ciclopirox 80 mg/mL	SolutionTopical	Preferred Pharmaceuticals, Inc.	68788-6797	68788-6797-06
Ciclopirox	Ciclopirox 10 mg/.96mL	ShampooTopical	Actavis Pharma, Inc.	0591-2159	00591-2159-90

All 24 Ciclopirox NDCs

Other NDCs under ANDA 078266

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

FDA NDC Directory listings under ANDA 078266
Product	Strength	Form · route	Labeler	Product NDC
Ciclopirox	Ciclopirox 7.7 mg/g	GelTopical	Bryant Ranch Prepack	63629-8620
Ciclopirox	Ciclopirox 7.7 mg/g	GelTopical	Bryant Ranch Prepack	63629-8621
Ciclopirox	Ciclopirox 7.7 mg/g	GelTopical	Bryant Ranch Prepack	63629-8622
Ciclopirox	Ciclopirox 7.7 mg/g	GelTopical	Bryant Ranch Prepack	72162-1126