Prescription drug · ANDA
Econazole Nitrate NDC 45802-466
Econazole nitrate 10 mg/g · Cream · Topical · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-466-11 | 4580204661145802046611 | 1 TUBE in 1 CARTON (45802-466-11) / 30 g in 1 TUBEMarketed from Nov 10, 2006 | |
| 45802-466-35 | 4580204663545802046635 | 1 TUBE in 1 CARTON (45802-466-35) / 15 g in 1 TUBEMarketed from Dec 21, 2006 | |
| 45802-466-53 | 4580204665345802046653 | 1 TUBE in 1 CARTON (45802-466-53) / 85 g in 1 TUBEMarketed from Aug 8, 2006 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
- 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 45802-466_a926c9d7-1215-47b9-a0ed-462941c209fcSPL ID a926c9d7-1215-47b9-a0ed-462941c209fcSPL set ID 3acc5e03-0339-4b23-945d-641746e81923RxCUI 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
N445802046611followed by a unit qualifier and the quantityPackage 45802-0466-11. 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.
About NDC 45802-466
- What is NDC 45802-466?
- 45802-466 is the product NDC for Econazole Nitrate, Econazole nitrate 10 mg/g cream, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Econazole Nitrate.
- What is the active ingredient?
- Econazole nitrate.
- Who is the labeler?
- Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Econazole Nitrate?
- 11 other product NDCs are listed under this name. See all Econazole Nitrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Econazole Nitrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Econazole Nitrate | Econazole nitrate 10 mg/g | CreamTopical | Encube Ethicals, Inc. | 21922-111 | 21922-0111-0421922-0111-0521922-0111-15 |
| Econazole Nitrate | Econazole nitrate 10 mg/g | CreamTopical | Aurobindo Pharma Limited | 59651-945 | 59651-0945-1459651-0945-3059651-0945-85 |
| Econazole Nitrate | Econazole nitrate 10 mg/g | Aerosol, FoamTopical | Trifluent Pharma, LLC | 73352-100 | 73352-0100-70 |
| Econazole Nitrate | Econazole nitrate 10 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8174 | 68788-8174-01 |
| Econazole Nitrate | Econazole nitrate 10 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8170 | 68788-8170-03 |
| Econazole Nitrate | Econazole nitrate 10 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-8645 | 63629-8645-01 |
| Econazole Nitrate | Econazole nitrate 10 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-8646 | 63629-8646-01 |
| Econazole Nitrate | Econazole nitrate 10 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-8647 | 63629-8647-01 |
| Econazole Nitrate | Econazole nitrate 10 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8884 | 68788-8884-03 |
| Econazole Nitrate | Econazole nitrate 10 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-1410 | 72162-1410-0272162-1410-0372162-1410-04 |
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 | 63629-8645 |
| Econazole Nitrate | Econazole nitrate 10 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-8646 |
| Econazole Nitrate | Econazole nitrate 10 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-8647 |
| 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 | 72162-1410 |