flucytosine

Generic: flucytosine

Labeler: laurus labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name flucytosine
Generic Name flucytosine
Labeler laurus labs limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

flucytosine 250 mg/1

Manufacturer
Laurus Labs Limited

Identifiers & Regulatory

Product NDC 42385-983
Product ID 42385-983_2aaf23f5-9b8f-4c5a-8c90-5c83765ad889
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218005
Listing Expiration 2026-12-31
Marketing Start 2025-07-24

Pharmacologic Class

Established (EPC)
nucleoside analog antifungal [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42385983
Hyphenated Format 42385-983

Supplemental Identifiers

RxCUI
197702 197703
UPC
0342385984019
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 ANDA218005 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (42385-983-01)
  • 10 BLISTER PACK in 1 CARTON (42385-983-27) / 10 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (2)

42385-983-01 100 CAPSULE in 1 BOTTLE (42385-983-01) 42385-983-27 10 BLISTER PACK in 1 CARTON (42385-983-27) / 10 CAPSULE in 1 BLISTER PACK

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": "2aaf23f5-9b8f-4c5a-8c90-5c83765ad889", "openfda": {"nui": ["N0000175459", "N0000175467"], "upc": ["0342385984019"], "unii": ["D83282DT06"], "rxcui": ["197702", "197703"], "spl_set_id": ["2aaf23f5-9b8f-4c5a-8c90-5c83765ad889"], "pharm_class_epc": ["Nucleoside Analog Antifungal [EPC]"], "manufacturer_name": ["Laurus Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (42385-983-01)", "package_ndc": "42385-983-01", "marketing_start_date": "20250724"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (42385-983-27)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "42385-983-27", "marketing_start_date": "20250724"}], "brand_name": "Flucytosine", "product_id": "42385-983_2aaf23f5-9b8f-4c5a-8c90-5c83765ad889", "dosage_form": "CAPSULE", "pharm_class": ["Nucleoside Analog Antifungal [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "42385-983", "generic_name": "Flucytosine", "labeler_name": "Laurus Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Flucytosine", "active_ingredients": [{"name": "FLUCYTOSINE", "strength": "250 mg/1"}], "application_number": "ANDA218005", "marketing_category": "ANDA", "marketing_start_date": "20250724", "listing_expiration_date": "20261231"}