Prescription drug · NDA
Ancobon (Flucytosine) NDC 0187-3554
Flucytosine 250 mg/1 · Capsule · Oral · Bausch Health US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0187-3554-10 | 0018735541000187355410 | 100 CAPSULE in 1 BOTTLE (0187-3554-10)Marketed from Nov 26, 1971 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Ancobon
- Generic name (nonproprietary)
- flucytosine
- Active ingredients
- Flucytosine — 250 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bausch Health US LLCNDC labeler code 0187
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017001
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Analog (EXT)
- Identifiers
- Product ID 0187-3554_2611b6d9-1f11-4c1d-a2b6-ae818d39d299SPL ID 2611b6d9-1f11-4c1d-a2b6-ae818d39d299SPL set ID aea0df00-a88c-4a16-abcf-750f3ff2004eRxCUI 197702, 197703, 207125, 207127UNII D83282DT06UPC 0301873554103, 0301873555100
- 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
N400187355410followed by a unit qualifier and the quantityPackage 00187-3554-10. 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 ANCOBON is 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. ANCOBON should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to ANCOBON (see MICROBIO…
Excerpt only. Read the full label for complete information.
About NDC 0187-3554
- What is NDC 0187-3554?
- 0187-3554 is the product NDC for Ancobon (flucytosine), Flucytosine 250 mg/1 capsule, listed with the FDA by Bausch Health US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ancobon (Flucytosine).
- What is the active ingredient?
- Flucytosine.
- Who is the labeler?
- Bausch Health US LLC, NDC labeler code 0187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ancobon?
- 1 other product NDC are listed under this name. See all Ancobon NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ancobon products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ancobonflucytosine | Flucytosine 500 mg/1 | CapsuleOral | Bausch Health US LLC | 0187-3555 | 00187-3555-10 |
Other NDCs under NDA 017001
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 |
|---|---|---|---|---|
| Ancobonflucytosine | Flucytosine 500 mg/1 | CapsuleOral | Bausch Health US LLC | 0187-3555 |