Prescription drug · ANDA
Ciclopirox NDC 45802-401
Ciclopirox 1 g/100mL · Shampoo · Topical · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-401-09 | 4580204010945802040109 | 120 mL in 1 BOTTLE (45802-401-09)Marketed from Feb 17, 2010 |
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 — 1 g/100mL
- Dosage form
- Shampoo
- Route
- Topical
- Labeler
- Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078594
- 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 45802-401_f9c45e64-a8ae-4bc5-9d1f-40eac9847c55SPL ID f9c45e64-a8ae-4bc5-9d1f-40eac9847c55SPL set ID c3722d52-407c-499b-a08b-b299609f203cRxCUI 250344UNII 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
N445802040109followed by a unit qualifier and the quantityPackage 45802-0401-09. 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)
Ciclopirox Shampoo, 1% is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. • Ciclopirox Shampoo, 1% is an antifungal indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 45802-401
- What is NDC 45802-401?
- 45802-401 is the product NDC for Ciclopirox, Ciclopirox 1 g/100mL shampoo, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 1 package NDC, 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?
- Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. 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 |