Prescription drug · ANDA
Fluconazole NDC 87063-204
Fluconazole 100 mg/1 · Tablet · Oral · ASCLEMED USA INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 87063-204-01 | 87063020401 | 1 TABLET in 1 BOTTLE (87063-204-01)Marketed from May 13, 2026 | |
| 87063-204-07 | 87063020407 | 7 TABLET in 1 BOTTLE (87063-204-07)Marketed from May 13, 2026 | |
| 87063-204-10 | 87063020410 | 10 TABLET in 1 BOTTLE (87063-204-10)Marketed from May 13, 2026 | |
| 87063-204-14 | 87063020414 | 14 TABLET in 1 BOTTLE (87063-204-14)Marketed from May 13, 2026 | |
| 87063-204-20 | 87063020420 | 20 TABLET in 1 BOTTLE (87063-204-20)Marketed from May 13, 2026 | |
| 87063-204-30 | 87063020430 | 30 TABLET in 1 BOTTLE (87063-204-30)Marketed from May 13, 2026 | |
| 87063-204-60 | 87063020460 | 60 TABLET in 1 BOTTLE (87063-204-60)Marketed from May 13, 2026 | |
| 87063-204-90 | 87063020490 | 90 TABLET in 1 BOTTLE (87063-204-90)Marketed from May 13, 2026 |
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
- ASCLEMED USA INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077731
- 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 87063-204_52428ad6-384c-5071-e063-6294a90ac345SPL ID 52428ad6-384c-5071-e063-6294a90ac345SPL set ID 2099c3a0-1911-4d4a-878a-36cf054bdd0bRxCUI 197698, 197699, 197700, 197701UNII 8VZV102JFY
- 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
N487063020401followed by a unit qualifier and the quantityPackage 87063-0204-01. 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: Vaginal candidiasis (vaginal yeast infections due to Candida ). Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 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 have …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077731
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 200 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8526 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | NorthStar Rx LLC | 16714-692 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | NorthStar Rx LLC | 16714-691 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | NorthStar Rx LLC | 16714-693 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | NorthStar Rx LLC | 16714-694 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4242 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4723 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Proficient Rx LP | 82804-146 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | A-S Medication Solutions | 50090-6751 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7293 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Pharmasource Meds, LLC | 82982-070 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-004 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-003 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-005 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-006 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | American Health Packaging | 68084-728 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | American Health Packaging | 68084-735 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | A-S Medication Solutions | 50090-6842 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | A-S Medication Solutions | 50090-2195 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Direct_Rx | 72189-516 |
Showing 20 of 40.