Ciclopirox Olamine
- Product NDC
- 80425-0225
- 11-digit product format
- 804250225
- Labeler code
- 80425
- Product ID
- 80425-0225_2a9b7c00-167c-4da0-e063-6394a90a926d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ciclopirox Olamine
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA090273
- Marketing category
- ANDA
- Marketing start
- 2023-01-09
- Substance
- CICLOPIROX OLAMINE
- 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 Olamine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CICLOPIROX OLAMINE | 7.7 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 50MD4SB4AP |
| Rxcui | 309289 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0225-1 | Ciclopirox Olamine | 30 g in 1 CARTON | CREAM | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0225 | CICLOPIROX OLAMINE CREAM [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250102_f186e394-7390-4b8a-e053-2a95a90abed1.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 |
|---|
| 80425-0225-1 | 80425022501 | 30 g in 1 CARTON (80425-0225-1) | 30 g | 2023-01-09 | 0000-00-00 | No | No | Current |