Home NDC 42794-010 Flucytosine
Product NDC 42794-010
11-digit product format 427940010
Labeler code 42794
Product ID 42794-010_f1f1b263-dcab-60e7-e053-2995a90ae493
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Flucytosine
Dosage form CAPSULE
Route ORAL
Labeler Sigmapharm Laboratories, LLC
Application ANDA201566
Marketing category ANDA
Marketing start 2018-06-01
Substance FLUCYTOSINE
Active strength 500 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 A201566-001 FLUCYTOSINE FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 A201566-002 FLUCYTOSINE FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28
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.
Product history page 1 of 3 · 82 observed 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 A201566-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201566-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201566-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201566-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201566-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201566-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201566-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201566-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201566-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201566-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201566-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201566-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201566-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201566-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201566-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201566-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201566-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201566-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201566-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201566-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201566-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201566-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201566-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201566-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201566-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201566-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201566-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201566-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201566-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201566-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201566-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201566-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201566-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201566-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201566-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A201566-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201566-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A201566-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201566-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A201566-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Flucytosine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUCYTOSINE 500 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 42794-010-08 Flucytosine 30 in 1 BOTTLE CAPSULE 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42794-010 FLUCYTOSINE CAPSULE [SIGMAPHARM LABORATORIES, LLC] 4 Current NDC, Legacy NDC, 1 package rows 20230111_3f2f67a8-2d13-4a7c-8e90-8b625c6ed98e.zip
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 Marketing end Sample Exclude flag Status 42794-010-08 42794001008 30 CAPSULE in 1 BOTTLE (42794-010-08) 30 capsule 2018-06-01 0000-00-00 No No Current