Home NDC 64980-180 Flucytosine
Product NDC 64980-180
11-digit product format 649800180
Labeler code 64980
Product ID 64980-180_80c82512-654a-137f-e053-2a91aa0a03ea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Flucytosine
Dosage form CAPSULE
Route ORAL
Labeler Rising Pharmaceuticals, Inc.
Application ANDA201566
Marketing category ANDA
Marketing start 2011-11-03
Marketing end 2019-04-30
Substance FLUCYTOSINE
Active strength 500 mg/1
Pharmacologic classes Nucleoside Analog [EXT],Nucleoside Analog Antifungal [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 88 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 2026-10-15 13:18:30 2026-09 A201566-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 A201566-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 A201566-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201566-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201566-001 FLUCYTOSINE 250MG CAPSULE / ORAL AB 2011-06-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201566-002 FLUCYTOSINE 500MG CAPSULE / ORAL AB 2011-06-28 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 3 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 Sigmapharm Laboratories, LLC 3f2f67a8-2d13-4a7c-8e90-8b625c6ed98e 2023-01-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201566 application number: ANDA201566