Ciclopirox
- Product NDC
- 42192-715
- 11-digit product format
- 421920715
- Labeler code
- 42192
- Product ID
- 42192-715_955307bc-4c2a-4d14-a1de-074a36e5ad92
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ciclopirox
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Acella Pharmaceuticals, LLC
- Application
- ANDA078172
- Marketing category
- ANDA
- Marketing start
- 2019-11-04
- Substance
- CICLOPIROX
- Active strength
- 80 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 | 80 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 19W019ZDRJ |
| Rxcui | 309291 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42192-715-06 | Ciclopirox | 1 in 1 CARTON | SOLUTION | 1 | | 3 |
| 42192-715-06 | Ciclopirox | 6.6 mL in 1 BOTTLE | SOLUTION | 6.6 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42192-715 | CICLOPIROX SOLUTION [ACELLA PHARMACEUTICALS, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240117_a08137a9-331f-4615-9752-e2cb52b3d8fc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42192-715-06 | 42192071506 | 1 BOTTLE in 1 CARTON (42192-715-06) / 6.6 mL in 1 BOTTLE | 1 bottle | 2019-11-04 | 0000-00-00 | No | No | Current |