Prescription drug · ANDA
Clotrimazole and Betamethasone Dipropionate NDC 80425-0344
Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g · Cream · Topical · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0344-1 | 8042503440180425034401 | 1 TUBE in 1 CARTON (80425-0344-1) / 15 g in 1 TUBEMarketed from Jun 15, 2023 |
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)
- 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
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075673
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 80425-0344_2a9bfe6a-6d75-b262-e063-6294a90a1cf3SPL ID 2a9bfe6a-6d75-b262-e063-6294a90a1cf3SPL set ID fe2ec7d2-23c2-e99f-e053-6294a90aa65aRxCUI 308714UNII G07GZ97H65, 826Y60901U
- 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
N480425034401followed by a unit qualifier and the quantityPackage 80425-0344-01. 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)
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 80425-0344
- What is NDC 80425-0344?
- 80425-0344 is the product NDC for Clotrimazole and Betamethasone Dipropionate, Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g cream, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clotrimazole and Betamethasone Dipropionate.
- What is the active ingredient?
- Clotrimazole, Betamethasone dipropionate.
- Who is the labeler?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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 and Betamethasone Dipropionate?
- 19 other product NDCs are listed under this name. See all Clotrimazole and Betamethasone Dipropionate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clotrimazole and Betamethasone Dipropionate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8419 | 68788-8419-01 |
| Clotrimazole And Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | Direct Rx | 72189-182 | 72189-0182-15 |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | REMEDYREPACK INC. | 70518-2352 | 70518-2352-00 |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | NuCare Pharmaceuticals,Inc. | 68071-4134 | 68071-4134-04 |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | Glenmark Pharmaceuticals Inc. USA | 68462-298 | 68462-0298-1768462-0298-55 |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | Proficient Rx LP | 71205-524 | 71205-0524-15 |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | Proficient Rx LP | 63187-095 | 63187-0095-1563187-0095-45 |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/mL; Betamethasone dipropionate .5 mg/mL | LotionTopical | Sun Pharmaceutical Industries, Inc. | 51672-1308 | 51672-1308-03 |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | Actavis Pharma, Inc. | 0472-0379 | 00472-0379-1500472-0379-45 |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | A-S Medication Solutions | 50090-0741 | 50090-0741-00 |
Other NDCs under ANDA 075673
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 | NORTHSTAR RX LLC | 16714-496 |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | A-S Medication Solutions | 50090-3121 |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | A-S Medication Solutions | 50090-4876 |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | A-S Medication Solutions | 50090-6474 |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 51672-4048 |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | Redpharm Drug | 67296-2272 |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8419 |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | REMEDYREPACK INC. | 70518-2352 |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | Sportpharm LLC | 85766-196 |