Home NDC 42385-983 Flucytosine
Product NDC 42385-983
11-digit product format 423850983
Labeler code 42385
Product ID 42385-983_2aaf23f5-9b8f-4c5a-8c90-5c83765ad889
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Flucytosine
Dosage form CAPSULE
Route ORAL
Labeler Laurus Labs Limited
Application ANDA218005
Marketing category ANDA
Marketing start 2025-07-24
Substance FLUCYTOSINE
Active strength 250 mg/1
Pharmacologic classes Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218005-001 FLUCYTOSINE FLUCYTOSINE 250MG CAPSULE / ORAL AB 2025-07-23 A218005-002 FLUCYTOSINE FLUCYTOSINE 500MG CAPSULE / ORAL AB 2025-07-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A218005-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2025-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218005-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2025-07-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218005-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2025-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218005-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2025-07-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218005-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2025-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218005-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2025-07-23 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218005-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2025-07-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218005-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2025-07-23 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Flucytosine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUCYTOSINE 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D83282DT06 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197702 Internal RxNorm lookup 197703 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42385-983-01 Flucytosine 100 in 1 BOTTLE CAPSULE 100 1 42385-983-27 Flucytosine 10 in 1 BLISTER PACK CAPSULE 10 1 42385-983-27 Flucytosine 10 in 1 CARTON CAPSULE 10 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42385-983-01 42385098301 100 CAPSULE in 1 BOTTLE (42385-983-01) 100 capsule 2025-07-24 No No Current 42385-983-27 42385098327 10 BLISTER PACK in 1 CARTON (42385-983-27) / 10 CAPSULE in 1 BLISTER PACK 10 blister pack 2025-07-24 No No Current