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 NDC11-digit (billing)PackageCopy
68462-455-35684620455356846204553530 g in 1 TUBE (68462-455-35)Marketed from Feb 29, 2012
68462-455-47684620455476846204554745 g in 1 TUBE (68462-455-47)Marketed from Feb 29, 2012
68462-455-946846204559468462045594100 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., USANDC labeler code 68462
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091595
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 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 .

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)

About NDC 68462-455

What is NDC 68462-455?
68462-455 is the product NDC for ciclopirox, Ciclopirox 7.7 mg/g gel, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. 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?
Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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/mLSolutionTopicalA-S Medication Solutions50090-656250090-6562-00
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

All 24 ciclopirox NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
ciclopiroxCiclopirox 7.7 mg/gGelTopicalBryant Ranch Prepack71335-2757

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