Prescription drug · ANDA
Clotrimazole and Betamethasone Dipropionate NDC 51672-1308
Clotrimazole 10 mg/mL; Betamethasone dipropionate .5 mg/mL · Lotion · Topical · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-1308-3 | 5167213080351672130803 | 1 BOTTLE in 1 CARTON (51672-1308-3) / 30 mL in 1 BOTTLEMarketed from Jul 28, 2004 |
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/mLBetamethasone dipropionate — .5 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076493
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 51672-1308_395c949b-3bfb-410d-e063-6394a90ad1d0SPL ID 395c949b-3bfb-410d-e063-6394a90ad1d0SPL set ID e4e9f244-4a85-4c0d-9917-93182c4a6e87RxCUI 308715UNII 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
N451672130803followed by a unit qualifier and the quantityPackage 51672-1308-03. 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 Clotrimazole and betamethasone dipropionate lotion is indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes and Trichophyton rubrum. Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. The efficacy of clotrimazole and betamethasone dipropionate lotion for the treatment of infections caused by zoophilic dermatophytes (e.g., Microsporum canis ) has not been estab…
Excerpt only. Read the full label for complete information.
About NDC 51672-1308
- What is NDC 51672-1308?
- 51672-1308 is the product NDC for Clotrimazole and Betamethasone Dipropionate, Clotrimazole 10 mg/mL; Betamethasone dipropionate .5 mg/mL lotion, listed with the FDA by Sun Pharmaceutical Industries, Inc.. 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?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. 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 | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0344 | 80425-0344-01 |
| 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/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 |