Flucytosine NDC 59651-331

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-331Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0331Add 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
59651-331-01	59651033101	100 CAPSULE in 1 BOTTLE (59651-331-01)Marketed from May 1, 2020

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): Flucytosine
Generic name (nonproprietary): flucytosine
Active ingredients: Flucytosine — 250 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213665
Marketing start: May 1, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Nucleoside Analog (EXT)
Identifiers: Product ID 59651-331_bf0234fe-1b94-44fb-a06d-86af5c5c07eaSPL ID bf0234fe-1b94-44fb-a06d-86af5c5c07eaSPL set ID 8b55832c-6771-4f5b-9aef-f88a1d22795eRxCUI 197702, 197703UNII D83282DT06
Pharmacologic class: Nucleoside Analog 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

N459651033101 followed by a unit qualifier and the quantity

Package 59651-0331-01. 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 Mar 2, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Flucytosine capsules are indicated only in the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus . Candida: Septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. Limited trials in pulmonary infections justify the use of flucytosine. Cryptococcus: Meningitis and pulmonary infections have been treated effectively. Studies in septicemias and urinary tract infections are limited, but good responses have been reported. Flucytosine capsules should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistan…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213665

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

FDA NDC Directory listings under ANDA 213665
Product	Strength	Form · route	Labeler	Product NDC
Flucytosine	Flucytosine 500 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-332
Flucytosine	Flucytosine 250 mg/1	CapsuleOral	American Health Packaging	60687-599
Flucytosine	Flucytosine 500 mg/1	CapsuleOral	American Health Packaging	60687-610