Prescription drug · ANDA
Clotrimazole and Betamethasone Dipropionate NDC 0168-0258
Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g · Cream · Topical · E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0168-0258-15 | 0016802581500168025815 | 15 g in 1 TUBE (0168-0258-15)Marketed from Jun 5, 2001 | |
| 0168-0258-46 | 0016802584600168025846 | 45 g in 1 TUBE (0168-0258-46)Marketed from Jun 5, 2001 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLCNDC labeler code 0168
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075502
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0168-0258_04a61040-37c4-4229-a1f9-8bd34c720e14SPL ID 04a61040-37c4-4229-a1f9-8bd34c720e14SPL set ID 55db730a-df6d-4950-9c26-91b06bdcef36RxCUI 308714UNII G07GZ97H65, 826Y60901UUPC 0301680258157
- 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
N400168025815followed by a unit qualifier and the quantityPackage 00168-0258-15. 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, 1%/0.05% (base) 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, 1%/0.05% (base) 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 , Trichoph…
Excerpt only. Read the full label for complete information.
About NDC 0168-0258
- What is NDC 0168-0258?
- 0168-0258 is the product NDC for Clotrimazole and Betamethasone Dipropionate, Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g cream, listed with the FDA by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC. It has 2 package NDCs, 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?
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, NDC labeler code 0168. 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/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 |