XURIDEN

Product NDC: 69468-152
Requested package NDC: 69468-152-30
11-digit product format: 694680152
Labeler code: 69468
Product ID: 69468-152_ad981e1e-0654-40b1-807a-f4e228c7ae11
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: uridine triacetate
Dosage form: GRANULE
Route: ORAL
Labeler: Wellstat Therapeutics Corporation
Application: NDA208169
Marketing category: NDA
Marketing start: 2015-09-08
Marketing end: 0000-00-00
Substance: URIDINE TRIACETATE
Active strength: 951 mg/g
Pharmacologic classes: Analogs/Derivatives [Chemical/Ingredient], Pyrimidine Analog [EPC], Pyrimidines [Chemical/Ingredient]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69468-152	69468-152-30	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N208169-001	XURIDEN	URIDINE TRIACETATE	2GM/PACKET	GRANULE / ORAL		RLD, RS	2015-09-04

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208169-001	XURIDEN	2GM/PACKET	GRANULE / ORAL	RLD, RS	2015-09-04	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208169-001	6258795	2023-07-10	Drug product	2015-10-22	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208169-001	ODE-98	2022-09-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208169-001	ODE-98	2022-09-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208169-001	ODE-98	2022-09-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208169-001	NCE	2020-09-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208169-001	ODE-98	2022-09-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208169-001	ODE-98	2022-09-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208169-001	ODE-98	2022-09-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208169-001	ODE-98	2022-09-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208169-001	ODE-98	2022-09-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208169-001	NCE	2020-09-04	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208169-001	ODE-98	2022-09-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208169-001	NCE	2020-09-04	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208169-001	ODE-98	2022-09-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208169-001	NCE	2020-09-04	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208169-001	ODE-98	2022-09-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208169-001	NCE	2020-09-04	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208169-001	ODE-98	2022-09-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208169-001	NCE	2020-09-04	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208169-001	ODE-98	2022-09-04	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N208169-001	ODE-98	2022-09-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208169-001	ODE-98	2022-09-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208169-001	ODE-98	2022-09-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208169-001	ODE-98	2022-09-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208169-001	ODE-98	2022-09-04	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
XURIDEN	URIDINE TRIACETATE	BTG International Inc	88ca4d2b-3905-474b-9fd6-c81474f2fb4b	2025-02-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208169 application number: NDA208169

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69468-152-02	EA - Each	69468-152	eaee91e3-48bd-4dd2-b7ed-549c0f9a3b39	1	2016-03-04
69468-152-30	EA - Each	69468-152	31885d6a-4217-4739-aa35-5c74662dcec9	1	2016-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
uridine triacetate	ACTIVE INGREDIENT	2WP61F175M	XURIDEN (URIDINE TRIACETATE) GRANULE [WELLSTAT THERAPEUTICS CORPORATION]	2
uridine triacetate	ACTIVE MOIETY	2WP61F175M	XURIDEN (URIDINE TRIACETATE) GRANULE [WELLSTAT THERAPEUTICS CORPORATION]	2
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	XURIDEN (URIDINE TRIACETATE) GRANULE [WELLSTAT THERAPEUTICS CORPORATION]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	XURIDEN (URIDINE TRIACETATE) GRANULE [WELLSTAT THERAPEUTICS CORPORATION]	2
ORANGE JUICE	INACTIVE INGREDIENT	5A9KE2L9L3	XURIDEN (URIDINE TRIACETATE) GRANULE [WELLSTAT THERAPEUTICS CORPORATION]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	XURIDEN (URIDINE TRIACETATE) GRANULE [WELLSTAT THERAPEUTICS CORPORATION]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2WP61F175M	URIDINE TRIACETATE	4105-38-8	URIDINE TRIACETATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69468-152-30	69468015230	30 PACKET in 1 CARTON (69468-152-30) > 2 g in 1 PACKET	30 packet	2015-09-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XURIDEN - Wellstat Therapeutics Corporation \| Almac Pharma Services \| Almac Sciences \| Butterworth Laboratories Limited	Wellstat Therapeutics Corporation \| Almac Pharma Services \| Almac Sciences \| Butterworth Laboratories Limited	2022-11-11	HUMAN PRESCRIPTION DRUG LABEL	6