Home NDC 50268-331 Flucytosine
Product NDC 50268-331
11-digit product format 502680331
Labeler code 50268
Product ID 50268-331_47e543f6-6e53-a812-e063-6294a90accbe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Flucytosine
Dosage form CAPSULE
Route ORAL
Labeler AvPAK
Application ANDA204652
Marketing category ANDA
Marketing start 2021-04-12
Substance FLUCYTOSINE
Active strength 250 mg/1
Pharmacologic classes Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]
NDC exclude flag No
Listing certified through 2027-12-31
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 A204652-001 FLUCYTOSINE FLUCYTOSINE 250MG CAPSULE / ORAL AB 2017-07-07 A204652-002 FLUCYTOSINE FLUCYTOSINE 500MG CAPSULE / ORAL AB 2017-07-07
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 A204652-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2017-07-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204652-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2017-07-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204652-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2017-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204652-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2017-07-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204652-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2017-07-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204652-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2017-07-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204652-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2017-07-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204652-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2017-07-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204652-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2017-07-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204652-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2017-07-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204652-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2017-07-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204652-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2017-07-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204652-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2017-07-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204652-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2017-07-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204652-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2017-07-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204652-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2017-07-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204652-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2017-07-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204652-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2017-07-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204652-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2017-07-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204652-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2017-07-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204652-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2017-07-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204652-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2017-07-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204652-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2017-07-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204652-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2017-07-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204652-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2017-07-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204652-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2017-07-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204652-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2017-07-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204652-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2017-07-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204652-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2017-07-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204652-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2017-07-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204652-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2017-07-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204652-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2017-07-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204652-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2017-07-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204652-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2017-07-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204652-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2017-07-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204652-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2017-07-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204652-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2017-07-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204652-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2017-07-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204652-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2017-07-07 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204652-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2017-07-07 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 2027-12-31 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 50268-331-11 Flucytosine 1 in 1 BLISTER PACK CAPSULE 1 4 50268-331-12 Flucytosine 20 in 1 BOX CAPSULE 20 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-331 FLUCYTOSINE CAPSULE [AVPAK] 3 Current NDC, Legacy NDC, 2 package rows 20240110_bfc817db-ab65-5cd7-e053-2995a90a8ee8.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Flucytosine FLUCYTOSINE AvPAK bfc817db-ab65-5cd7-e053-2995a90a8ee8 2026-01-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204652 application number: ANDA204652 ndc (product): 50268-331 Flucytosine FLUCYTOSINE Major Pharmaceuticals 01d874f9-e073-4092-94ad-da361551d4bf 2026-01-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204652 application number: ANDA204652 Flucytosine FLUCYTOSINE Lupin Pharmaceuticals,Inc. 5721b46a-4a9f-46c2-8804-a9bad4d5f80a 2025-08-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204652 application number: ANDA204652 Flucytosine FLUCYTOSINE Novel Laboratories, Inc. ee98e0a9-c125-4b5c-ba4e-ca3c9a1f2b90 2022-05-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204652 application number: ANDA204652
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 50268-331-11 50268033111 1 in 1 BLISTER PACK Historical 50268-331-12 50268033112 20 BLISTER PACK in 1 BOX (50268-331-12) / 1 CAPSULE in 1 BLISTER PACK (50268-331-11) 20 blister pack 2021-04-12 0000-00-00 No No Current