Diflucan (fluconazole) NDC 0049-3450

NDC codes

FDA NDC Directory

Product NDC (as listed)0049-3450Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00049-3450Add 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
0049-3450-19	00049345019	1 BOTTLE in 1 CARTON (0049-3450-19) / 35 mL in 1 BOTTLEMarketed from Dec 23, 1993

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Diflucan
Generic name (nonproprietary): fluconazole
Active ingredients: Fluconazole — 1400 mg/35mL
Dosage form: Powder, For suspension
Route: Oral
Labeler: Roerig
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020090
Marketing start: Dec 23, 1993
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 0049-3450_c835d7dd-af65-4b2c-a92c-42d1986f902dSPL ID c835d7dd-af65-4b2c-a92c-42d1986f902dSPL set ID f694c617-3383-416c-91b6-b94fda371204RxCUI 197698, 197699, 197700, 197701, 201900, 201901, 207106, 207107, 207108, 207112, 310352, 310353UNII 8VZV102JFYUPC 0300493420300, 0300493430309, 0300493410301
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

N400049345019 followed by a unit qualifier and the quantity

Package 00049-3450-19. 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 Apr 2, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE DIFLUCAN (fluconazole) is 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, DIFLUCAN 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 DIFLUCAN (fluconazole) for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing DIFLUCAN to amphotericin B in non-HIV infected patients have not been co…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 020090

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

FDA NDC Directory listings under NDA 020090
Product	Strength	Form · route	Labeler	Product NDC
Fluconazole	Fluconazole 10 mg/mL	Powder, For suspensionOral	Mylan Pharmaceuticals Inc.	59762-5029
Fluconazole	Fluconazole 40 mg/mL	Powder, For suspensionOral	Mylan Pharmaceuticals Inc.	59762-5030