Home NDC 43386-771 Flucytosine
Product NDC 43386-771
11-digit product format 433860771
Labeler code 43386
Product ID 43386-771_f404c3d3-ea62-4918-aebd-58b00b661bb9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Flucytosine
Dosage form CAPSULE
Route ORAL
Labeler Lupin Pharmaceuticals,Inc.
Application ANDA204652
Marketing category ANDA
Marketing start 2017-07-07
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 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 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 43386-771-01 Flucytosine 100 in 1 BOTTLE CAPSULE 100 7 43386-771-03 Flucytosine 30 in 1 BOTTLE CAPSULE 30 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43386-771 FLUCYTOSINE CAPSULE [LUPIN PHARMACEUTICALS,INC.] 6 Current NDC, Legacy NDC, 2 package rows 20250515_5721b46a-4a9f-46c2-8804-a9bad4d5f80a.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 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 ndc (product): 43386-771 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 43386-771-01 43386077101 100 CAPSULE in 1 BOTTLE (43386-771-01) 100 capsule 2017-07-07 0000-00-00 Yes No Current 43386-771-03 43386077103 30 CAPSULE in 1 BOTTLE (43386-771-03) 30 capsule 2017-07-07 0000-00-00 No No Current