Prescription drug · ANDA
Flucytosine NDC 60687-599
Flucytosine 250 mg/1 · Capsule · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-599-21 | 60687059921 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-599-21) / 1 CAPSULE in 1 BLISTER PACK (60687-599-11)Marketed from Dec 17, 2021 |
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
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213665
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Analog (EXT)
- Identifiers
- Product ID 60687-599_284ff75e-657f-cfe0-e063-6394a90a8cabSPL ID 284ff75e-657f-cfe0-e063-6394a90a8cabSPL set ID 4b1c40b2-e0fb-47d5-b821-889b3090cebeRxCUI 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
N460687059921followed by a unit qualifier and the quantityPackage 60687-0599-21. 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 213665
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 | Aurobindo Pharma Limited | 59651-331 |
| Flucytosine | Flucytosine 500 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-332 |
| Flucytosine | Flucytosine 500 mg/1 | CapsuleOral | American Health Packaging | 60687-610 |