CICLOPIROX
- Product NDC
- 63629-8620
- 11-digit product format
- 636298620
- Labeler code
- 63629
- Product ID
- 63629-8620_3045fc9f-f068-4648-8607-187b050ea189
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CICLOPIROX
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078266
- Marketing category
- ANDA
- Marketing start
- 2009-01-07
- Substance
- CICLOPIROX
- Active strength
- 7.7 mg/g
- 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 | 7.7 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 19W019ZDRJ |
| Rxcui | 313941 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-8620-1 | CICLOPIROX | 1 in 1 CARTON | GEL | 1 | | 104 |
| 63629-8620-1 | CICLOPIROX | 30 g in 1 TUBE | GEL | 30 | | 104 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8620 | CICLOPIROX GEL [BRYANT RANCH PREPACK] | 104 | Current NDC, Legacy NDC, 2 package rows | 20240608_9861c88d-528f-4e30-8c1e-56ac3afec76c.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 |
|---|
| 63629-8620-1 | 63629862001 | 1 TUBE in 1 CARTON (63629-8620-1) / 30 g in 1 TUBE | 1 tube | 2009-01-07 | 0000-00-00 | No | No | Current |