Over-the-counter drug · NDA
sunmark Clotrimazole 3 (clotrimazole) NDC 49348-379
Clotrimazole 2 g/100g · Cream · Vaginal · Strategic Sourcing Services LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49348-379-54 | 49348037954 | 1 TUBE, WITH APPLICATOR in 1 CARTON (49348-379-54) / 21 g in 1 TUBE, WITH APPLICATORMarketed from Feb 12, 2013 |
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)
- sunmark Clotrimazole 3Suffix: Clotrimazole 3
- Generic name (nonproprietary)
- clotrimazole
- Active ingredients
- Clotrimazole — 2 g/100g
- Dosage form
- Cream
- Route
- Vaginal
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021143
- Marketing start
- Marketing end
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 49348-379_3a76faa8-aa42-362d-e063-6294a90a2eabSPL ID 3a76faa8-aa42-362d-e063-6294a90a2eabSPL set ID 0bc5d91a-c4ea-4fe9-80e0-6f76aa073e7bRxCUI 199603UNII G07GZ97H65UPC 0010939578334
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N449348037954followed by a unit qualifier and the quantityPackage 49348-0379-54. 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)
Use treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021143
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 2 g/100g | CreamVaginal | Foster and Thrive (Mckesson /STRATEGIC SOURCING SERVICES LLC) | 70677-1231 |
| Good Neighbor Pharmacy Clotrimazole 3clotrimazole | Clotrimazole 2 g/100g | CreamVaginal | AmerisourceBergen | 24385-110 |
| Clotrimazole | Clotrimazole 2 g/100g | CreamVaginal | Sun Pharmaceutical Industries, Inc. | 51672-2062 |
| CVS Pharmacy Clotrimazole 3clotrimazole | Clotrimazole 2 g/100g | CreamVaginal | CVS Pharmacy | 69842-062 |
| Walgreens Clotrimazole 3clotrimazole | Clotrimazole 2 g/100g | CreamVaginal | Walgreen Company | 0363-2062 |