Flucytosine

Product NDC: 43386-770
Requested package NDC: 43386-770-01
11-digit product format: 433860770
Labeler code: 43386
Product ID: 43386-770_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: 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
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.

Application-product, TE code table
Application-product	TE code
A204652-001	AB
A204652-002	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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204652-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204652-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204652-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204652-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204652-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204652-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204652-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204652-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204652-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204652-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204652-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204652-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204652-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204652-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204652-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204652-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204652-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204652-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204652-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204652-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204652-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204652-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204652-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204652-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204652-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204652-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204652-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204652-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204652-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204652-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204652-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204652-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204652-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204652-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204652-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204652-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204652-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204652-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204652-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204652-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Flucytosine
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 · 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5721b46a-4a9f-46c2-8804-a9bad4d5f80a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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
43386-770-01	Flucytosine	100 in 1 BOTTLE	CAPSULE	100		7
43386-770-03	Flucytosine	30 in 1 BOTTLE	CAPSULE	30		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43386-770-01	EA - Each	43386-770	cf94ba9b-1ff4-4e21-8130-b1c4072c5f29	1	2017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43386-770	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 (package): 43386-770-01 ndc (product): 43386-770 ndc11 (package): 43386077001
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

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
197702	flucytosine 250 MG Oral Capsule	PSN	01d874f9-e073-4092-94ad-da361551d4bf	7
197702	flucytosine 250 MG Oral Capsule	PSN	5721b46a-4a9f-46c2-8804-a9bad4d5f80a	7
197703	flucytosine 500 MG Oral Capsule	PSN	01d874f9-e073-4092-94ad-da361551d4bf	7
197703	flucytosine 500 MG Oral Capsule	PSN	5721b46a-4a9f-46c2-8804-a9bad4d5f80a	7
197702	flucytosine 250 MG Oral Capsule	SCD	01d874f9-e073-4092-94ad-da361551d4bf	7
197702	flucytosine 250 MG Oral Capsule	SCD	5721b46a-4a9f-46c2-8804-a9bad4d5f80a	7
197703	flucytosine 500 MG Oral Capsule	SCD	01d874f9-e073-4092-94ad-da361551d4bf	7
197703	flucytosine 500 MG Oral Capsule	SCD	5721b46a-4a9f-46c2-8804-a9bad4d5f80a	7
197702	flucytosine 250 MG Oral Capsule	PSN	bfc817db-ab65-5cd7-e053-2995a90a8ee8	4
197703	flucytosine 500 MG Oral Capsule	PSN	bfc817db-ab65-5cd7-e053-2995a90a8ee8	4
197702	flucytosine 250 MG Oral Capsule	SCD	bfc817db-ab65-5cd7-e053-2995a90a8ee8	4
197703	flucytosine 500 MG Oral Capsule	SCD	bfc817db-ab65-5cd7-e053-2995a90a8ee8	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43386-770-01	43386077001	100 CAPSULE in 1 BOTTLE (43386-770-01)	100 capsule	2017-07-07	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FLUCYTOSINE Capsules USP Rx only	AvPAK	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	4
FLUCYTOSINE Capsules USP Rx only	Major Pharmaceuticals	2026-01-07	HUMAN PRESCRIPTION DRUG LABEL	7
FLUCYTOSINE Capsules USP Rx only	Lupin Pharmaceuticals,Inc. \| Novel Laboratories, Inc.	2025-08-26	HUMAN PRESCRIPTION DRUG LABEL	7
Flucytosine Capsules, USP Rx Only 8435225/1020F	American Health Packaging	2022-01-21	HUMAN PRESCRIPTION DRUG LABEL	5