What is NDC 42385-984?

42385-984 is the product NDC for Flucytosine, Flucytosine 500 mg/1 capsule, listed with the FDA by Laurus Labs Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Laurus Labs Limited, NDC labeler code 42385. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Flucytosine?

16 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Flucytosine NDC 42385-984 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42385-984Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42385-0984Add 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
42385-984-01	4238509840142385098401	100 CAPSULE in 1 BOTTLE (42385-984-01)Marketed from Jul 24, 2025
42385-984-27	4238509842742385098427	10 BLISTER PACK in 1 CARTON (42385-984-27) / 10 CAPSULE in 1 BLISTER PACKMarketed from Jul 24, 2025

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: Laurus Labs LimitedNDC labeler code 42385
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218005
Marketing start: Jul 24, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Nucleoside Analog (EXT)
Identifiers: Product ID 42385-984_2aaf23f5-9b8f-4c5a-8c90-5c83765ad889SPL ID 2aaf23f5-9b8f-4c5a-8c90-5c83765ad889SPL set ID 2aaf23f5-9b8f-4c5a-8c90-5c83765ad889RxCUI 197702, 197703UNII D83282DT06UPC 0342385984019
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

N442385098401 followed by a unit qualifier and the quantity

Package 42385-0984-01. 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 Jul 28, 2025. 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)

About NDC 42385-984

What is NDC 42385-984?: 42385-984 is the product NDC for Flucytosine, Flucytosine 500 mg/1 capsule, listed with the FDA by Laurus Labs Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Flucytosine.
What is the active ingredient?: Flucytosine.
Who is the labeler?: Laurus Labs Limited, NDC labeler code 42385. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Flucytosine?: 16 other product NDCs are listed under this name. See all Flucytosine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Flucytosine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Flucytosine	Flucytosine 250 mg/1	CapsuleOral	Laurus Labs Limited	42385-983	42385-0983-0142385-0983-27
Flucytosine	Flucytosine 250 mg/1	CapsuleOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-860	23155-0860-0123155-0860-03
Flucytosine	Flucytosine 500 mg/1	CapsuleOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-861	23155-0861-0123155-0861-03
Flucytosine	Flucytosine 250 mg/1	CapsuleOral	American Health Packaging	60687-599	60687-0599-21
Flucytosine	Flucytosine 500 mg/1	CapsuleOral	American Health Packaging	60687-610	60687-0610-21
Flucytosine	Flucytosine 250 mg/1	CapsuleOral	AvPAK	50268-331	50268-0331-12
Flucytosine	Flucytosine 500 mg/1	CapsuleOral	AvPAK	50268-332	50268-0332-12
Flucytosine	Flucytosine 250 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-331	59651-0331-01
Flucytosine	Flucytosine 250 mg/1	CapsuleOral	Sigmapharm Laboratories, LLC	42794-009	42794-0009-08
Flucytosine	Flucytosine 500 mg/1	CapsuleOral	Sigmapharm Laboratories, LLC	42794-010	42794-0010-08

All 17 Flucytosine NDCs

Other NDCs under ANDA 218005

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

FDA NDC Directory listings under ANDA 218005
Product	Strength	Form · route	Labeler	Product NDC
Flucytosine	Flucytosine 250 mg/1	CapsuleOral	Laurus Labs Limited	42385-983