flucytosine

Generic: flucytosine

Labeler: lupin pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name flucytosine
Generic Name flucytosine
Labeler lupin pharmaceuticals,inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

flucytosine 250 mg/1

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-771
Product ID 43386-771_f404c3d3-ea62-4918-aebd-58b00b661bb9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204652
Listing Expiration 2026-12-31
Marketing Start 2017-07-07

Pharmacologic Class

Established (EPC)
nucleoside analog antifungal [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43386771
Hyphenated Format 43386-771

Supplemental Identifiers

RxCUI
197702 197703
UPC
0343386770014 0343386771035
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 ANDA204652 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (43386-771-01)
source: ndc

Packages (1)

43386-771-01 100 CAPSULE in 1 BOTTLE (43386-771-01)

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": "f404c3d3-ea62-4918-aebd-58b00b661bb9", "openfda": {"nui": ["N0000175459", "N0000175467"], "upc": ["0343386770014", "0343386771035"], "unii": ["D83282DT06"], "rxcui": ["197702", "197703"], "spl_set_id": ["5721b46a-4a9f-46c2-8804-a9bad4d5f80a"], "pharm_class_epc": ["Nucleoside Analog Antifungal [EPC]"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "100 CAPSULE in 1 BOTTLE (43386-771-01)", "package_ndc": "43386-771-01", "marketing_start_date": "20170707"}], "brand_name": "Flucytosine", "product_id": "43386-771_f404c3d3-ea62-4918-aebd-58b00b661bb9", "dosage_form": "CAPSULE", "pharm_class": ["Nucleoside Analog Antifungal [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "43386-771", "generic_name": "Flucytosine", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Flucytosine", "active_ingredients": [{"name": "FLUCYTOSINE", "strength": "250 mg/1"}], "application_number": "ANDA204652", "marketing_category": "ANDA", "marketing_start_date": "20170707", "listing_expiration_date": "20261231"}