Fluconazole NDC 16714-695

NDC codes

FDA NDC Directory

Product NDC (as listed)16714-695Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16714-0695Add 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
16714-695-01	16714069501	1 BOTTLE in 1 CARTON (16714-695-01) / 35 mL in 1 BOTTLEMarketed from Sep 18, 2009

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 — 10 mg/mL
Dosage form: Powder, For suspension
Route: Oral
Labeler: NorthStar Rx LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 079150
Marketing start: Sep 18, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Azoles (Chemical structure)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers: Product ID 16714-695_95e12350-efed-4dad-8ec3-6aa48fdc1512SPL ID 95e12350-efed-4dad-8ec3-6aa48fdc1512SPL set ID afde17e7-b95b-4cd5-97eb-e361724014bdRxCUI 310352, 310353UNII 8VZV102JFYUPC 0316714696010
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

N416714069501 followed by a unit qualifier and the quantity

Package 16714-0695-01. 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 Aug 22, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Fluconazole for oral suspension is indicated for the treatment of: Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole for oral suspension was 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 for oral suspension for AIDS patients with cryptococcal meningitis , please see CLINICAL STUDIES section. Studies comparing fluconazole for oral suspension to amphotericin B in non-HIV infected patients have not been conducted…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 079150

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

FDA NDC Directory listings under ANDA 079150
Product	Strength	Form · route	Labeler	Product NDC
Fluconazole	Fluconazole 40 mg/mL	Powder, For suspensionOral	NorthStar Rx LLC	16714-696
Fluconazole	Fluconazole 10 mg/mL	Powder, For suspensionOral	Aurobindo Pharma Limited	65862-299
Fluconazole	Fluconazole 40 mg/mL	Powder, For suspensionOral	Aurobindo Pharma Limited	65862-300
Fluconazole	Fluconazole 10 mg/mL	Powder, For suspensionOral	Rising Pharma Holdings, Inc.	57237-149
Fluconazole	Fluconazole 40 mg/mL	Powder, For suspensionOral	Rising Pharma Holdings, Inc.	57237-150