Prescription drug · ANDA
Clotrimazole/Betameth NDC 72189-518
Betamethasone dipropionate .5 mg/g; Clotrimazole 10 mg/g · Cream · Topical · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-518-15 | 7218905181572189051815 | 15 g in 1 TUBE (72189-518-15)Marketed from Oct 25, 2023 |
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/Betameth
- Generic name (nonproprietary)
- clotrimazole/betameth
- Active ingredients
- Betamethasone dipropionate — .5 mg/gClotrimazole — 10 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Direct_RxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076002
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 72189-518_4d3aa580-669c-dddb-e063-6294a90a1152SPL ID 4d3aa580-669c-dddb-e063-6294a90a1152SPL set ID 08901233-7d36-e5d9-e063-6394a90af33dRxCUI 308714UNII 826Y60901U, G07GZ97H65
- 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
N472189051815followed by a unit qualifier and the quantityPackage 72189-0518-15. 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.
Excerpt only. Read the full label for complete information.
About NDC 72189-518
- What is NDC 72189-518?
- 72189-518 is the product NDC for Clotrimazole/Betameth, Betamethasone dipropionate .5 mg/g; Clotrimazole 10 mg/g cream, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clotrimazole/Betameth.
- What is the active ingredient?
- Betamethasone dipropionate, Clotrimazole.
- Who is the labeler?
- Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Clotrimazole/Betameth?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 076002
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 | Actavis Pharma, Inc. | 0472-0379 |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | A-S Medication Solutions | 50090-0741 |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | Proficient Rx LP | 63187-095 |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-8758 |