Flucytosine

Product NDC: 42494-339
11-digit product format: 424940339
Labeler code: 42494
Product ID: 42494-339_2a26a9f9-9188-4608-a587-77f76ec22b56
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Flucytosine
Dosage form: CAPSULE
Route: ORAL
Labeler: Cameron Pharmaceuticals, LLC
Application: NDA017001
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2017-07-26
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42494-339		D	Discontinued by firm	2026-08-11
excluded package	package	42494-339	42494-339-01	D	Discontinued by firm	2026-08-11
excluded package	package	42494-339	42494-339-03	D	Discontinued by firm	2026-08-11

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
N017001-001	ANCOBON	FLUCYTOSINE	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982
N017001-002	ANCOBON	FLUCYTOSINE	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N017001-001	AB
N017001-002	AB

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	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017001-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017001-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017001-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017001-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017001-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017001-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017001-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017001-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017001-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017001-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017001-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017001-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017001-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017001-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017001-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017001-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017001-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017001-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017001-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017001-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017001-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017001-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017001-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017001-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017001-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017001-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017001-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017001-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017001-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017001-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017001-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017001-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017001-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017001-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017001-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017001-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017001-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017001-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017001-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017001-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42494-339-01	EA - Each	42494-339	536c32ff-9e52-4eb6-9def-5d188fad5c79	1	2017-08-11
42494-339-03	EA - Each	42494-339	74aca2a6-0dfb-4b1d-9815-c6ed5202b554	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42494-339	FLUCYTOSINE CAPSULE [CAMERON PHARMACEUTICALS, LLC]	6	Legacy NDC	20221007_9b386823-8b36-4bf3-b627-3814fae931cf.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
ANCOBON	FLUCYTOSINE	Bausch Health US LLC	aea0df00-a88c-4a16-abcf-750f3ff2004e	2022-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017001 application number: NDA017001

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D83282DT06	FLUCYTOSINE	2022-85-7	FLUCYTOSINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42494-339-01	42494033901	100 CAPSULE in 1 BOTTLE (42494-339-01)	100 capsule	2017-07-26	0000-00-00	No	No	Current
42494-339-03	42494033903	30 CAPSULE in 1 BOTTLE, PLASTIC (42494-339-03)	30 capsule	2021-04-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Flucytosine Capsules Rx only	Bryant Ranch Prepack	2024-03-19	HUMAN PRESCRIPTION DRUG LABEL	105
Flucytosine Capsules	Bryant Ranch Prepack	2023-08-25	HUMAN PRESCRIPTION DRUG LABEL	100
Flucytosine Capsules Rx only	Bryant Ranch Prepack	2023-03-16	HUMAN PRESCRIPTION DRUG LABEL	102
Flucytosine Capsules	Cameron Pharmaceuticals, LLC \| Bausch Health Companies Inc.	2022-10-05	HUMAN PRESCRIPTION DRUG LABEL	6
Flucytosine Capsules Rx only	Bryant Ranch Prepack	2022-06-06	HUMAN PRESCRIPTION DRUG LABEL	100