flucytosine

Generic: flucytosine

Labeler: sigmapharm laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name flucytosine
Generic Name flucytosine
Labeler sigmapharm laboratories, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

flucytosine 250 mg/1

Manufacturer
Sigmapharm Laboratories, LLC

Identifiers & Regulatory

Product NDC 42794-009
Product ID 42794-009_f1f1b263-dcab-60e7-e053-2995a90ae493
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201566
Listing Expiration 2026-12-31
Marketing Start 2018-06-01

Pharmacologic Class

Established (EPC)
nucleoside analog antifungal [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42794009
Hyphenated Format 42794-009

Supplemental Identifiers

RxCUI
197702 197703
UPC
0342794010088 0342794009082
UNII
D83282DT06
NUI
N0000175459 N0000175467

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name flucytosine (source: ndc)
Generic Name flucytosine (source: ndc)
Application Number ANDA201566 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (42794-009-08)
source: ndc

Packages (1)

42794-009-08 30 CAPSULE in 1 BOTTLE (42794-009-08)

Ingredients (1)

flucytosine (250 mg/1)

Linked Drug Pages (1)

Flucytosine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f1f1b263-dcab-60e7-e053-2995a90ae493", "openfda": {"nui": ["N0000175459", "N0000175467"], "upc": ["0342794010088", "0342794009082"], "unii": ["D83282DT06"], "rxcui": ["197702", "197703"], "spl_set_id": ["3f2f67a8-2d13-4a7c-8e90-8b625c6ed98e"], "pharm_class_epc": ["Nucleoside Analog Antifungal [EPC]"], "manufacturer_name": ["Sigmapharm Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (42794-009-08)", "package_ndc": "42794-009-08", "marketing_start_date": "20180601"}], "brand_name": "Flucytosine", "product_id": "42794-009_f1f1b263-dcab-60e7-e053-2995a90ae493", "dosage_form": "CAPSULE", "pharm_class": ["Nucleoside Analog Antifungal [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "42794-009", "generic_name": "Flucytosine", "labeler_name": "Sigmapharm Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Flucytosine", "active_ingredients": [{"name": "FLUCYTOSINE", "strength": "250 mg/1"}], "application_number": "ANDA201566", "marketing_category": "ANDA", "marketing_start_date": "20180601", "listing_expiration_date": "20261231"}