Prescription drug · ANDA
Flucytosine NDC 43386-770
Flucytosine 500 mg/1 · Capsule · Oral · Lupin Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43386-770-01 | 4338607700143386077001 | 100 CAPSULE in 1 BOTTLE (43386-770-01)Marketed from Jul 7, 2017 · Sample package |
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
- Lupin Pharmaceuticals,Inc.NDC labeler code 43386
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204652
- Marketing start
- Listing expires
- Other FDA classes
- Nucleoside Analog (EXT)
- Identifiers
- Product ID 43386-770_f404c3d3-ea62-4918-aebd-58b00b661bb9SPL ID f404c3d3-ea62-4918-aebd-58b00b661bb9SPL set ID 5721b46a-4a9f-46c2-8804-a9bad4d5f80aRxCUI 197702, 197703UNII D83282DT06UPC 0343386770014, 0343386771035
- 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
N443386077001followed by a unit qualifier and the quantityPackage 43386-0770-01. 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 USP 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. Flucytosine Capsules USP should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of r…
Excerpt only. Read the full label for complete information.
About NDC 43386-770
- What is NDC 43386-770?
- 43386-770 is the product NDC for Flucytosine, Flucytosine 500 mg/1 capsule, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 1 package NDC, 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?
- Lupin Pharmaceuticals,Inc., NDC labeler code 43386. 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.
Related NDCs: other Flucytosine products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 500 mg/1 | CapsuleOral | Laurus Labs Limited | 42385-984 | 42385-0984-0142385-0984-27 |
| 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 |
Other NDCs under ANDA 204652
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 | Major Pharmaceuticals | 0904-6834 |
| Flucytosine | Flucytosine 500 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-6835 |
| Flucytosine | Flucytosine 500 mg/1 | CapsuleOral | Novel Laboratories, Inc. | 40032-770 |
| Flucytosine | Flucytosine 250 mg/1 | CapsuleOral | Novel Laboratories, Inc. | 40032-771 |
| Flucytosine | Flucytosine 250 mg/1 | CapsuleOral | Lupin Pharmaceuticals,Inc. | 43386-771 |
| Flucytosine | Flucytosine 250 mg/1 | CapsuleOral | AvPAK | 50268-331 |
| Flucytosine | Flucytosine 500 mg/1 | CapsuleOral | AvPAK | 50268-332 |