Zileuton

Product NDC: 64980-206
11-digit product format: 649800206
Labeler code: 64980
Product ID: 64980-206_984587a3-4875-4ad3-af6e-11b90fe705a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zileuton
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA204929
Marketing category: ANDA
Marketing start: 2017-03-21
Substance: ZILEUTON
Active strength: 600 mg/1
Pharmacologic classes: 5-Lipoxygenase Inhibitor [EPC], 5-Lipoxygenase Inhibitors [MoA], Decreased Leukotriene Production [PE]
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 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204929-001	ZILEUTON	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204929-001	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 2 · 42 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	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-03-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-03-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-03-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-03-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-03-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-03-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-03-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-03-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-03-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-03-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-03-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-03-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-03-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-03-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204929-001	ZILEUTON	600MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-03-17	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204929-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204929-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204929-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204929-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204929-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204929-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204929-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204929-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204929-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204929-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204929-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204929-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204929-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204929-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204929-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204929-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204929-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204929-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204929-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204929-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204929-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204929-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204929-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204929-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204929-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204929-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204929-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204929-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204929-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204929-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204929-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204929-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204929-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204929-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204929-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204929-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204929-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204929-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204929-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204929-001	AB	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZILEUTON	600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V1L22WVE2S	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
730834	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
fd382540-b390-4e86-a94a-988ea89c93a8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0ab1cd6a-2e03-4fd2-842b-497a1f1ff461	Product name	4	20231219
4fad46b7-5f43-5163-8976-8a0f23153295	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64980-206-12	Zileuton	120 in 1 BOTTLE	TABLET, EXTENDED RELEASE	120		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64980-206-12	EA - Each	64980-206	05c8dd64-7b21-40a1-9a43-cb8e135b441a	1	2017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64980-206	ZILEUTON TABLET, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.]	7	Current NDC, Legacy NDC, 1 package rows	20240524_fd382540-b390-4e86-a94a-988ea89c93a8.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
Zileuton	ZILEUTON	Rising Pharma Holdings, Inc.	fd382540-b390-4e86-a94a-988ea89c93a8	2024-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204929 application number: ANDA204929 ndc (product): 64980-206

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V1L22WVE2S	ZILEUTON	111406-87-2	ZILEUTON

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
730834	zileuton 600 MG 12HR Extended Release Oral Tablet	PSN	fd382540-b390-4e86-a94a-988ea89c93a8	7
730834	12 HR zileuton 600 MG Extended Release Oral Tablet	SCD	fd382540-b390-4e86-a94a-988ea89c93a8	7
730834	zileuton 600 MG 12 HR Extended Release Oral Tablet	SY	fd382540-b390-4e86-a94a-988ea89c93a8	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64980-206-12	64980020612	120 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-206-12)	2017-03-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zileuton	Rising Pharma Holdings, Inc. \| Cohance Lifesciences Limited	2024-05-15	Human Prescription Drug Label	7