Prescription drug · ANDA
Clotrimazole (Clotrimazole topical) NDC 70954-036
Clotrimazole 10 mg/mL · Solution · Topical · Novitium Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-036-20 | 70954003620 | 1 BOTTLE in 1 CARTON (70954-036-20) / 30 mL in 1 BOTTLEMarketed from Feb 18, 2019 |
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 topical
- Active ingredients
- Clotrimazole — 10 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Novitium Pharma LLCNDC labeler code 70954
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209815
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 70954-036_7d0a148e-294d-4975-9937-5244473f665dSPL ID 7d0a148e-294d-4975-9937-5244473f665dSPL set ID 02df90b9-4879-4e73-b03a-0e96f3d099eaRxCUI 309370UNII G07GZ97H65UPC 0370954036203
- 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
N470954003620followed by a unit qualifier and the quantityPackage 70954-0036-20. 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 & USAGE Prescription Clotrimazole Topical Solution product is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur . This formulation is also available as a nonprescription product 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 fluoccosum, and Microsporum canis .
Excerpt only. Read the full label for complete information.
About NDC 70954-036
- What is NDC 70954-036?
- 70954-036 is the product NDC for Clotrimazole (clotrimazole topical), Clotrimazole 10 mg/mL solution, listed with the FDA by Novitium Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clotrimazole (Clotrimazole topical).
- What is the active ingredient?
- Clotrimazole.
- Who is the labeler?
- Novitium Pharma LLC, NDC labeler code 70954. 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 |