Prescription drug · ANDA
Clotrimazole and Betamethasone Dipropionate NDC 68462-298
Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g · Cream · Topical · Glenmark Pharmaceuticals Inc. USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-298-17 | 68462029817 | 15 g in 1 TUBE (68462-298-17)Marketed from Nov 6, 2015 | |
| 68462-298-55 | 68462029855 | 45 g in 1 TUBE (68462-298-55)Marketed from Nov 6, 2015 |
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)
- Clotrimazole and Betamethasone Dipropionate
- Generic name (nonproprietary)
- clotrimazole and betamethasone dipropionate
- Active ingredients
- Clotrimazole — 10 mg/gBetamethasone dipropionate — .5 mg/g
- Dosage form
- Cream
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202894
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68462-298_2fc6dcb9-879f-4d6e-8194-4a30af922986SPL ID 2fc6dcb9-879f-4d6e-8194-4a30af922986SPL set ID 8dcd24cb-e568-428a-88ac-737d115cc54dRxCUI 308714UNII G07GZ97H65, 826Y60901UUPC 0368462298176, 0368462298558
- Pharmacologic class
- Azole Antifungal; Corticosteroid
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
N468462029817followed by a unit qualifier and the quantityPackage 68462-0298-17. 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)
Clotrimazole and betamethasone dipropionate cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older. Clotrimazole and betamethasone dipropionate cream contains a combination of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202894
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 |
|---|---|---|---|---|
| Clotrimazole And Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | Direct Rx | 72189-182 |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | Proficient Rx LP | 71205-524 |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | NuCare Pharmaceuticals,Inc. | 68071-4134 |