Fluconazole NDC 85534-0049

NDC codes

FDA NDC Directory

Product NDC (as listed)85534-0049Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85534-0049Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
85534-0049-0	85534004900	1 TABLET in 1 BOTTLE (85534-0049-0)Marketed from Jul 3, 2026

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): Fluconazole
Generic name (nonproprietary): fluconazole
Active ingredients: Fluconazole — 150 mg/1
Dosage form: Tablet
Route: Oral
Labeler: HAWAII REPACK, INC.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076665
Marketing start: Jul 29, 2004
Listing expires: Dec 31, 2027
Other FDA classes: Azoles (Chemical structure)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers: Product ID 85534-0049_55adedaa-a28a-27e3-e063-6394a90a63adSPL ID 55adedaa-a28a-27e3-e063-6394a90a63adSPL set ID 8aa296e2-ad8d-42f6-8b41-468e2b9cdfb8RxCUI 197699UNII 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

N485534004900 followed by a unit qualifier and the quantity

Package 85534-0049-00. 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 Jul 3, 2026.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076665

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 076665
Product	Strength	Form · route	Labeler	Product NDC
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 100 mg/1	TabletOral	Chartwell RX, LLC	62135-131
Fluconazole	Fluconazole 200 mg/1	TabletOral	Chartwell RX, LLC	62135-133