Ciclopirox
- Product NDC
- 0168-0314
- 11-digit product format
- 001680314
- Labeler code
- 0168
- Product ID
- 0168-0314_ae069f7e-d070-401d-8d1b-3e835d9f48c8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ciclopirox
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
- Application
- ANDA076422
- Marketing category
- ANDA
- Marketing start
- 2004-08-06
- Marketing end
- 0000-00-00
- Substance
- CICLOPIROX OLAMINE
- Active strength
- 8 mg/mL
- Pharmacologic classes
- Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 0168-0314-30 | Ciclopirox | 30 mL in 1 BOTTLE | LOTION | 30 | | 4 |
| 0168-0314-60 | Ciclopirox | 60 mL in 1 BOTTLE | LOTION | 60 | | 4 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0168-0314 | CICLOPIROX LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 4 | Legacy NDC, 2 package rows | 20150929_4aeae21c-8c03-4fa9-a191-6b1e9000cbdb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 0168-0314-30 | 00168031430 | 30 mL in 1 BOTTLE | 30 ml | Historical |
| 0168-0314-60 | 00168031460 | 60 mL in 1 BOTTLE | 60 ml | Historical |