Over-the-counter drug · ANDA
Clotrimazole NDC 68788-9665
Clotrimazole 1 g/100g · Cream · Vaginal · Preferred Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-9665-4 | 68788966504 | 1 TUBE in 1 CARTON (68788-9665-4) / 45 g in 1 TUBEMarketed from Aug 5, 2013 |
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
- Generic name (nonproprietary)
- clotrimazole
- Active ingredients
- Clotrimazole — 1 g/100g
- Dosage form
- Cream
- Route
- Vaginal
- Labeler
- Preferred Pharmaceuticals, Inc.NDC labeler code 68788
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 072641
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 68788-9665_61f64e2c-533a-4712-8c95-fb2fbf37c054SPL ID 61f64e2c-533a-4712-8c95-fb2fbf37c054SPL set ID 624827d6-dbf8-4f3d-a8c0-c92474cad7deRxCUI 309368UNII G07GZ97H65
- 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
N468788966504followed by a unit qualifier and the quantityPackage 68788-9665-04. 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)
Uses • treats vaginal yeast infections • relieves external itching and irritation due to a vaginal yeast infection
Excerpt only. Read the full label for complete information.
About NDC 68788-9665
- What is NDC 68788-9665?
- 68788-9665 is the product NDC for Clotrimazole, Clotrimazole 1 g/100g cream, listed with the FDA by Preferred Pharmaceuticals, Inc.. It has 1 package NDC, 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?
- Preferred Pharmaceuticals, Inc., NDC labeler code 68788. 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?
- 64 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 072641
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 1 g/100g | CreamVaginal | NuCare Pharmaceuticals,Inc. | 68071-4026 |
| Clotrimazole | Clotrimazole 1 g/100g | CreamVaginal | YYBA CORP | 73581-450 |
| Clotrimazole | Clotrimazole 1 g/100g | CreamVaginal | STRATEGIC SOURCING SERVICES LLC | 70677-1262 |
| Clotrimazole | Clotrimazole 1 g/100g | CreamVaginal | A-S Medication Solutions | 50090-0614 |
| Clotrimazole | Clotrimazole 1 g/100g | CreamVaginal | Sun Pharmaceutical Industries, Inc. | 51672-2003 |