Ertaczo
- Product NDC
- 85437-004
- 11-digit product format
- 854370004
- Labeler code
- 85437
- Product ID
- 85437-004_4ee1de22-cab4-606f-e063-6394a90afd63
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertaconazole Nitrate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Coral Way Pharma, LLC
- Application
- NDA021385
- Marketing category
- NDA
- Marketing start
- 2025-11-07
- Substance
- SERTACONAZOLE NITRATE
- Active strength
- 20 mg/g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ertaczo
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SERTACONAZOLE NITRATE | 20 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1DV05410M5 |
| Rxcui | 250511, 580294 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85437-004-60 | Ertaczo | 60 g in 1 TUBE | CREAM | 60 | | 2 |
| 85437-004-60 | Ertaczo | 1 in 1 CARTON | CREAM | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85437-004-60 | 85437000460 | 1 TUBE in 1 CARTON (85437-004-60) / 60 g in 1 TUBE | 1 tube | 2025-11-07 | No | No | Historical |