Prescription drug · ANDA
Econazole Nitrate NDC 63629-8647
Econazole nitrate 10 mg/g · Cream · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8647-1 | 63629864701 | 1 TUBE in 1 CARTON (63629-8647-1) / 85 g in 1 TUBEMarketed from Aug 8, 2006 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Econazole Nitrate
- Generic name (nonproprietary)
- econazole nitrate
- Active ingredients
- Econazole nitrate — 10 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076479
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 63629-8647_e55d252a-ff23-4fe5-b884-2dc696ffb7beSPL ID e55d252a-ff23-4fe5-b884-2dc696ffb7beSPL set ID ae173340-7611-4dc8-99a7-7669bc4fc97dRxCUI 857366UNII H438WYN10E
- Pharmacologic class
- Azole Antifungal
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N463629864701followed by a unit qualifier and the quantityPackage 63629-8647-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Econazole Nitrate Cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076479
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Econazole Nitrate | Econazole nitrate 10 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-1410 |
| Econazole Nitrate | Econazole nitrate 10 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8170 |
| Econazole Nitrate | Econazole nitrate 10 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8884 |
| Econazole Nitrate | Econazole nitrate 10 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-8645 |
| Econazole Nitrate | Econazole nitrate 10 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-8646 |
| Econazole Nitrate | Econazole nitrate 10 mg/g | CreamTopical | Padagis Israel Pharmaceuticals Ltd | 45802-466 |