Prescription drug · ANDA
Ciclopirox Olamine NDC 68462-297
Ciclopirox olamine 7.7 mg/g · Cream · Topical · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-297-17 | 6846202971768462029717 | 15 g in 1 CARTON (68462-297-17)Marketed from Nov 13, 2009 | |
| 68462-297-35 | 6846202973568462029735 | 30 g in 1 CARTON (68462-297-35)Marketed from Nov 13, 2009 | |
| 68462-297-92 | 6846202979268462029792 | 90 g in 1 CARTON (68462-297-92)Marketed from Nov 13, 2009 |
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 Olamine
- Generic name (nonproprietary)
- ciclopirox olamine
- Active ingredients
- Ciclopirox olamine — 7.7 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090273
- 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 68462-297_740c1d91-06c1-4508-9e94-e5308bec9be3SPL ID 740c1d91-06c1-4508-9e94-e5308bec9be3SPL set ID 7385cf42-9f80-4542-8e0f-a0228aa9b43aRxCUI 309289UNII 50MD4SB4APUPC 0368462297353
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
N468462029717followed by a unit qualifier and the quantityPackage 68462-0297-17. 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 Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum , and Microsporum canis ; candidiasis (moniliasis) due to Candida albicans ; and tinea (pityriasis) versicolor due to Malassezia furfur.
Excerpt only. Read the full label for complete information.
About NDC 68462-297
- What is NDC 68462-297?
- 68462-297 is the product NDC for Ciclopirox Olamine, Ciclopirox olamine 7.7 mg/g cream, 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 Olamine.
- What is the active ingredient?
- Ciclopirox olamine.
- 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 Olamine?
- 15 other product NDCs are listed under this name. See all Ciclopirox Olamine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ciclopirox Olamine 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 Olamine | Ciclopirox olamine 7.7 mg/g | CreamTopical | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0225 | 80425-0225-01 |
| Ciclopirox Olamine | Ciclopirox olamine 7.7 mg/g | CreamTopical | Cosette Pharmaceuticals, Inc. | 0713-0638 | 00713-0638-1500713-0638-1800713-0638-31 |
| Ciclopirox Olamine | Ciclopirox olamine 7.7 mg/mL | SuspensionTopical | Padagis Israel Pharmaceuticals Ltd | 45802-400 | 45802-0400-4645802-0400-49 |
| Ciclopirox Olamine | Ciclopirox olamine 7.7 mg/100mL | SuspensionTopical | Bryant Ranch Prepack | 63629-2522 | 63629-2522-01 |
| Ciclopirox Olamine | Ciclopirox olamine 7.7 mg/100mL | SuspensionTopical | Bryant Ranch Prepack | 63629-8627 | 63629-8627-01 |
| Ciclopirox Olamine | Ciclopirox olamine 7.7 mg/100mL | SuspensionTopical | Bryant Ranch Prepack | 71335-2717 | 71335-2717-01 |
| Ciclopirox Olamine | Ciclopirox olamine 7.7 mg/100mL | SuspensionTopical | Bryant Ranch Prepack | 71335-2915 | 71335-2915-01 |
| Ciclopirox Olamine | Ciclopirox olamine 7.7 mg/100mL | SuspensionTopical | Bryant Ranch Prepack | 72162-1406 | 72162-1406-0372162-1406-06 |
| Ciclopirox olamine | Ciclopirox olamine 7.7 mg/g | CreamTopical | Padagis Israel Pharmaceuticals Ltd | 45802-138 | 45802-0138-1145802-0138-1845802-0138-35 |
| Ciclopirox Olamine | Ciclopirox olamine 7.7 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-8624 | 63629-8624-01 |
Other NDCs under ANDA 090273
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 Olamine | Ciclopirox olamine 7.7 mg/g | CreamTopical | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0225 |