Prescription drug · ANDA
Ciclopirox Olamine NDC 63629-2522
Ciclopirox olamine 7.7 mg/100mL · Suspension · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2522-1 | 6362925220163629252201 | 1 BOTTLE in 1 CARTON (63629-2522-1) / 30 mL in 1 BOTTLEMarketed from Dec 29, 2006 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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/100mL
- Dosage form
- Suspension
- Route
- Topical
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077676
- 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 63629-2522_a7508900-9b1a-49bc-ab18-b86cdf1025d9SPL ID a7508900-9b1a-49bc-ab18-b86cdf1025d9SPL set ID 246585a0-e53e-4f54-8f8b-76536011ab23RxCUI 309290UNII 50MD4SB4AP
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
N463629252201followed by a unit qualifier and the quantityPackage 63629-2522-01. 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 Topical Suspension USP, 0.77% (w/w) (Lotion) 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; cutaneous 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 63629-2522
- What is NDC 63629-2522?
- 63629-2522 is the product NDC for Ciclopirox Olamine, Ciclopirox olamine 7.7 mg/100mL suspension, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 | Glenmark Pharmaceuticals Inc., USA | 68462-297 | 68462-0297-1768462-0297-3568462-0297-92 |
| 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 | 63629-8627 | 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 077676
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/mL | SuspensionTopical | Padagis Israel Pharmaceuticals Ltd | 45802-400 |
| Ciclopirox Olamine | Ciclopirox olamine 7.7 mg/100mL | SuspensionTopical | Bryant Ranch Prepack | 63629-8627 |
| Ciclopirox Olamine | Ciclopirox olamine 7.7 mg/100mL | SuspensionTopical | Bryant Ranch Prepack | 71335-2717 |
| Ciclopirox Olamine | Ciclopirox olamine 7.7 mg/100mL | SuspensionTopical | Bryant Ranch Prepack | 71335-2915 |
| Ciclopirox Olamine | Ciclopirox olamine 7.7 mg/100mL | SuspensionTopical | Bryant Ranch Prepack | 72162-1406 |