ciclopirox NDC 68462-455

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-455Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0455Add 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
68462-455-35	68462045535	30 g in 1 TUBE (68462-455-35)Marketed from Feb 29, 2012
68462-455-47	68462045547	45 g in 1 TUBE (68462-455-47)Marketed from Feb 29, 2012
68462-455-94	68462045594	100 g in 1 TUBE (68462-455-94)Marketed from Feb 29, 2012

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): ciclopirox
Generic name (nonproprietary): ciclopirox
Active ingredients: Ciclopirox — 7.7 mg/g
Dosage form: Gel
Route: Topical
Labeler: Glenmark Pharmaceuticals Inc., USA
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091595
Marketing start: Feb 29, 2012
Listing expires: Dec 31, 2027
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 68462-455_941ab9d0-0c94-48f9-a8d2-8f164b050a6cSPL ID 941ab9d0-0c94-48f9-a8d2-8f164b050a6cSPL set ID 3c22416e-4293-4ba5-a983-137cbc6022dbRxCUI 313941UNII 19W019ZDRJUPC 0368462455357

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

N468462045535 followed by a unit qualifier and the quantity

Package 68462-0455-35. 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 Jan 23, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Superficial Dermatophyte Infections Ciclopirox gel 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 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 091595

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

FDA NDC Directory listings under ANDA 091595
Product	Strength	Form · route	Labeler	Product NDC
ciclopirox	Ciclopirox 7.7 mg/g	GelTopical	Bryant Ranch Prepack	71335-2757