ANCOBON

Product NDC: 0187-3555
11-digit product format: 001873555
Labeler code: 0187
Product ID: 0187-3555_2611b6d9-1f11-4c1d-a2b6-ae818d39d299
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Flucytosine
Dosage form: CAPSULE
Route: ORAL
Labeler: Bausch Health US LLC
Application: NDA017001
Marketing category: NDA
Marketing start: 1971-11-26
Substance: FLUCYTOSINE
Active strength: 500 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
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: ANCOBON
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUCYTOSINE	500 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197702	Internal RxNorm lookup
197703	Internal RxNorm lookup
207125	Internal RxNorm lookup
207127	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
aea0df00-a88c-4a16-abcf-750f3ff2004e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4cbbebe-6acb-b5dc-a199-fda613aaf07b	Product name	5	20200728

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0187-3555-10	ANCOBON	100 in 1 BOTTLE	CAPSULE	100		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-3555-10	EA - Each	0187-3555	20109bd2-bec8-45ab-8b3c-56ea65e91b6f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Flucytosine	ACTIVE INGREDIENT	D83282DT06	ANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
Flucytosine	ACTIVE MOIETY	D83282DT06	ANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	ANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	ANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
SODIUM PROPIONATE	INACTIVE INGREDIENT	DK6Y9P42IN	ANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0187-3555	ANCOBON (FLUCYTOSINE) CAPSULE [BAUSCH HEALTH US LLC]	16	Current NDC, Legacy NDC, 1 package rows	20220513_aea0df00-a88c-4a16-abcf-750f3ff2004e.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 ndc (product): 0187-3555

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
207125	Ancobon 250 MG Oral Capsule	PSN	aea0df00-a88c-4a16-abcf-750f3ff2004e	16
207127	Ancobon 500 MG Oral Capsule	PSN	aea0df00-a88c-4a16-abcf-750f3ff2004e	16
197702	flucytosine 250 MG Oral Capsule	PSN	aea0df00-a88c-4a16-abcf-750f3ff2004e	16
197703	flucytosine 500 MG Oral Capsule	PSN	aea0df00-a88c-4a16-abcf-750f3ff2004e	16
207125	flucytosine 250 MG Oral Capsule [Ancobon]	SBD	aea0df00-a88c-4a16-abcf-750f3ff2004e	16
207127	flucytosine 500 MG Oral Capsule [Ancobon]	SBD	aea0df00-a88c-4a16-abcf-750f3ff2004e	16
197702	flucytosine 250 MG Oral Capsule	SCD	aea0df00-a88c-4a16-abcf-750f3ff2004e	16
197703	flucytosine 500 MG Oral Capsule	SCD	aea0df00-a88c-4a16-abcf-750f3ff2004e	16
207125	Ancobon 250 MG Oral Capsule	SY	aea0df00-a88c-4a16-abcf-750f3ff2004e	16
207127	Ancobon 500 MG Oral Capsule	SY	aea0df00-a88c-4a16-abcf-750f3ff2004e	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0187-3555-10	00187355510	100 CAPSULE in 1 BOTTLE (0187-3555-10)	100 capsule	1971-11-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ANCOBON ® (flucytosine) Capsules	Bausch Health US LLC \| Bausch Health Companies, Inc.	2022-02-02	HUMAN PRESCRIPTION DRUG LABEL	16