Ciclopirox
- Product NDC
- 62135-814
- 11-digit product format
- 621350814
- Labeler code
- 62135
- Product ID
- 62135-814_41b5be9e-4f27-f7aa-e063-6394a90a00d8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ciclopirox
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA078046
- Marketing category
- ANDA
- Marketing start
- 2007-09-18
- Substance
- CICLOPIROX
- Active strength
- 71.3 mg/mL
- Pharmacologic classes
- Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ciclopirox
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CICLOPIROX | 71.3 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 19W019ZDRJ |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-814-45 | Ciclopirox | 6.6 mL in 1 BOTTLE | SOLUTION | 6.6 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-814 | CICLOPIROX SOLUTION [CHARTWELL RX, LLC] | 1 | Current NDC, 1 package rows | 20240405_8ce98020-5615-4332-bf57-72777e2ce038.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-814-45 | 62135081445 | 6.6 mL in 1 BOTTLE (62135-814-45) | 6.6 ml | 2024-03-28 | No | No | Current |