Prescription drug · ANDA
Clotrimazole NDC 68462-181
Clotrimazole 10 mg/g · Cream · Topical · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-181-17 | 68462018117 | 15 g in 1 TUBE (68462-181-17)Marketed from Aug 4, 2010 | |
| 68462-181-35 | 68462018135 | 30 g in 1 TUBE (68462-181-35)Marketed from Aug 4, 2010 | |
| 68462-181-47 | 68462018147 | 45 g in 1 TUBE (68462-181-47)Marketed from Aug 4, 2010 | |
| 68462-181-48 | 68462018148 | 2 TUBE in 1 CARTON (68462-181-48) / 45 g in 1 TUBEMarketed from Aug 4, 2010 |
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
- Generic name (nonproprietary)
- clotrimazole
- Active ingredients
- Clotrimazole — 10 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090219
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 68462-181_23d83b26-b5da-4474-9468-4909134295d1SPL ID 23d83b26-b5da-4474-9468-4909134295d1SPL set ID f6898117-14f3-42d2-bc0e-d296add3ad70RxCUI 309367UNII G07GZ97H65UPC 0368462181355
- Pharmacologic class
- Azole Antifungal
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
N468462018117followed by a unit qualifier and the quantityPackage 68462-0181-17. 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)
INDICATIONS AND USAGE Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes , Epidermophyton floccosum , and Microsporum canis.
Excerpt only. Read the full label for complete information.
About NDC 68462-181
- What is NDC 68462-181?
- 68462-181 is the product NDC for Clotrimazole, Clotrimazole 10 mg/g cream, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clotrimazole.
- What is the active ingredient?
- Clotrimazole.
- Who is the labeler?
- Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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?
- 63 other product NDCs are listed under this name. See all Clotrimazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clotrimazole 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 | Clotrimazole 1 g/mL | SolutionTopical | InvaDerm Corporation | 71457-523 | 71457-0523-1071457-0523-30 |
| Clotrimazole | Clotrimazole 1 g/mL | SolutionTopical | YYBA CORP | 73581-448 | 73581-0448-30 |
| Clotrimazole | Clotrimazole 1 g/100g | CreamVaginal | YYBA CORP | 73581-450 | 73581-0450-01 |
| Clotrimazole | Clotrimazole 100 kg/100kg | GranuleTopical | Shaanxi Shuvita Biotech Co., Ltd | 87879-001 | 87879-0001-01 |
| Clotrimazole | Clotrimazole 10 mg/mL | SolutionTopical | Preferred Pharmaceuticals Inc. | 68788-4155 | 68788-4155-03 |
| Clotrimazole | Clotrimazole 1 g/mL | SolutionTopical | Preferred Pharmaceuticals Inc. | 68788-4080 | 68788-4080-01 |
| Clotrimazole | Clotrimazole 1 g/mL | SolutionTopical | AvPAK | 50268-044 | 50268-0044-30 |
| Clotrimazole | Clotrimazole 10 mg/g | CreamVaginal | Cardinal Health (Leader) 70000 | 70000-0729 | 70000-0729-01 |
| Clotrimazole | Clotrimazole 1 g/100g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8830 | 68788-8830-02 |
| Clotrimazole | Clotrimazole 1 g/100mL | SolutionTopical | Rugby Laboratories, Inc. | 0536-1443 | 00536-1443-70 |
Other NDCs under ANDA 090219
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 | Clotrimazole 10 mg/g | CreamTopical | A-S Medication Solutions | 50090-7343 |
| Clotrimazole | Clotrimazole 10 mg/g | CreamTopical | Redpharm Drug | 67296-2252 |