Home NDC 64380-897 Flucytosine
Product NDC 64380-897
11-digit product format 643800897
Labeler code 64380
Product ID 64380-897_1d5d3028-7e9d-4568-b119-8bfb0d894847
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Flucytosine
Dosage form CAPSULE
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA212632
Marketing category ANDA
Marketing start 2022-03-06
Marketing end 0000-00-00
Substance FLUCYTOSINE
Active strength 250 mg/1
Pharmacologic classes Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A212632-001 FLUCYTOSINE FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 A212632-002 FLUCYTOSINE FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17
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 2 · 76 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 2026-08-18 06:07:40 2026-07 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2020-04-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2020-04-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL 2020-04-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL 2020-04-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212632-001 FLUCYTOSINE 250MG CAPSULE / ORAL 2020-04-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A212632-002 FLUCYTOSINE 500MG CAPSULE / ORAL 2020-04-17 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64380-897-06 Flucytosine 100 in 1 BOTTLE CAPSULE 100 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-897 FLUCYTOSINE CAPSULE [STRIDES PHARMA SCIENCE LIMITED] 9 Legacy NDC, 1 package rows 20240304_7ff9f22f-4667-40c1-b81b-01d904f6a356.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Flucytosine FLUCYTOSINE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. f4c63d98-f03f-43f5-8c1f-e9ac6087312b 2025-11-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212632 application number: ANDA212632
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 64380-897-06 64380089706 100 CAPSULE in 1 BOTTLE (64380-897-06) 100 capsule 2022-03-06 0000-00-00 No No Current