Flucytosine NDC 42794-010

NDC codes

FDA NDC Directory

Product NDC (as listed)42794-010Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42794-0010Add 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
42794-010-08	42794001008	30 CAPSULE in 1 BOTTLE (42794-010-08)Marketed from Jun 1, 2018

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 — 500 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Sigmapharm Laboratories, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201566
Marketing start: Jun 1, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Nucleoside Analog (EXT)
Identifiers: Product ID 42794-010_f1f1b263-dcab-60e7-e053-2995a90ae493SPL ID f1f1b263-dcab-60e7-e053-2995a90ae493SPL set ID 3f2f67a8-2d13-4a7c-8e90-8b625c6ed98eRxCUI 197702, 197703UNII D83282DT06UPC 0342794010088, 0342794009082
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

N442794001008 followed by a unit qualifier and the quantity

Package 42794-0010-08. 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 Jan 10, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Flucytosine Capsules, USP 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, USP should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201566

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

FDA NDC Directory listings under ANDA 201566
Product	Strength	Form · route	Labeler	Product NDC
Flucytosine	Flucytosine 250 mg/1	CapsuleOral	Sigmapharm Laboratories, LLC	42794-009