Ciclopirox Olamine
- Product NDC
- 63629-8627
- 11-digit product format
- 636298627
- Labeler code
- 63629
- Product ID
- 63629-8627_c6d0d8c1-929a-4b96-a780-29212701185f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ciclopirox Olamine
- Dosage form
- SUSPENSION
- Route
- TOPICAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA077676
- Marketing category
- ANDA
- Marketing start
- 2006-12-29
- Substance
- CICLOPIROX OLAMINE
- Active strength
- 7.7 mg/100mL
- 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/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 50MD4SB4AP |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-8627-1 | Ciclopirox Olamine | 60 mL in 1 BOTTLE | SUSPENSION | 60 | | 104 |
| 63629-8627-1 | Ciclopirox Olamine | 1 in 1 CARTON | SUSPENSION | 1 | | 104 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8627 | CICLOPIROX OLAMINE SUSPENSION [BRYANT RANCH PREPACK] | 104 | Current NDC, Legacy NDC, 2 package rows | 20250216_29c638cd-b6cb-4e17-8cb3-636253a2e47c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-8627-1 | 63629862701 | 1 BOTTLE in 1 CARTON (63629-8627-1) / 60 mL in 1 BOTTLE | 1 bottle | 2006-12-29 | 0000-00-00 | No | No | Current |