Prescription drug · ANDA
Fluconazole NDC 62135-131
Fluconazole 100 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-131-30 | 62135013130 | 30 TABLET in 1 BOTTLE (62135-131-30)Marketed from Dec 8, 2022 |
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)
- Fluconazole
- Generic name (nonproprietary)
- fluconazole
- Active ingredients
- Fluconazole — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076665
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 62135-131_25892746-5194-5955-e063-6294a90a3b7fSPL ID 25892746-5194-5955-e063-6294a90a3b7fSPL set ID f86ea347-78f5-43b8-9574-a52569a4237bRxCUI 197698, 197699, 197700, 197701UNII 8VZV102JFYUPC 0362135133306, 0362135130305, 0362135132774, 0362135131302
- 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N462135013130followed by a unit qualifier and the quantityPackage 62135-0131-30. 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 Fluconazole tablets are indicated for the treatment of: 1. Vaginal candidiasis (vaginal yeast infections due to Candida ). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablet was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076665
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 |
|---|---|---|---|---|
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | HAWAII REPACK, INC. | 85534-0049 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-587 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Chartwell RX, LLC | 62135-132 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | Chartwell RX, LLC | 62135-130 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Chartwell RX, LLC | 62135-133 |