Ciclopirox NDC 63629-8622

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-8622Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-8622Add 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
63629-8622-1	63629862201	1 TUBE in 1 CARTON (63629-8622-1) / 100 g in 1 TUBEMarketed from Jan 7, 2009

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 — 7.7 mg/g
Dosage form: Gel
Route: Topical
Labeler: Bryant Ranch Prepack
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 63629-8622_52d76980-71dc-4e9d-aeea-1a101eef6b3cSPL ID 52d76980-71dc-4e9d-aeea-1a101eef6b3cSPL set ID 808733e7-9402-4f9b-99ce-ca6d04ad4aeeRxCUI 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

N463629862201 followed by a unit qualifier and the quantity

Package 63629-8622-01. 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 Jun 15, 2023.

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)

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	72162-1126
Ciclopirox	Ciclopirox 7.7 mg/g	GelTopical	Padagis US LLC	0574-2061
Ciclopirox	Ciclopirox 7.7 mg/g	GelTopical	Bryant Ranch Prepack	63629-8620
Ciclopirox	Ciclopirox 7.7 mg/g	GelTopical	Bryant Ranch Prepack	63629-8621