Prescription drug · ANDA
ciclopirox NDC 68462-455
Ciclopirox 7.7 mg/g · Gel · Topical · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-455-35 | 6846204553568462045535 | 30 g in 1 TUBE (68462-455-35)Marketed from Feb 29, 2012 | |
| 68462-455-47 | 6846204554768462045547 | 45 g in 1 TUBE (68462-455-47)Marketed from Feb 29, 2012 | |
| 68462-455-94 | 6846204559468462045594 | 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., 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
N468462045535followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other ciclopirox products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under ANDA 091595
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| ciclopirox | Ciclopirox 7.7 mg/g | GelTopical | Bryant Ranch Prepack | 71335-2757 |