CICLOPIROX
- Product NDC
- 21922-053
- 11-digit product format
- 219220053
- Labeler code
- 21922
- Product ID
- 21922-053_c81092f6-fe1e-4f70-8699-69c4cdce214f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ciclopirox
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Encube Ethicals, Inc.
- Application
- ANDA077687
- Marketing category
- ANDA
- Marketing start
- 2023-11-09
- 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 |
|---|
| 21922-053-51 | CICLOPIROX | 6.6 mL in 1 BOTTLE, WITH APPLICATOR | SOLUTION | 6.6 | | 3 |
| 21922-053-51 | CICLOPIROX | 1 in 1 CARTON | SOLUTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21922-053 | CICLOPIROX SOLUTION [ENCUBE ETHICALS PRIVATE LIMITED] | 1 | Current NDC, 2 package rows | 20231110_79084b47-7481-4926-9837-e08f633b1ddf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 21922-053-51 | 21922005351 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (21922-053-51) / 6.6 mL in 1 BOTTLE, WITH APPLICATOR | 2023-11-09 | No | No | Current |