Prescription drug · ANDA
Flucytosine NDC 42385-984
Flucytosine 500 mg/1 · Capsule · Oral · Laurus Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42385-984-01 | 42385098401 | 100 CAPSULE in 1 BOTTLE (42385-984-01)Marketed from Jul 24, 2025 | |
| 42385-984-27 | 42385098427 | 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 Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218005
- Marketing start
- Listing expires
- 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
N442385098401followed by a unit qualifier and the quantityPackage 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 . 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.
Other NDCs under ANDA 218005
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Flucytosine | Flucytosine 250 mg/1 | CapsuleOral | Laurus Labs Limited | 42385-983 |