DYANAVEL XR

Product NDC: 27808-106
Requested package NDC: 27808-106-01
11-digit product format: 278080106
Labeler code: 27808
Product ID: 27808-106_c92bfc3d-e9d4-42d2-ae4e-1590d5610f52
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amphetamine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Tris Pharma Inc
Application: NDA210526
Marketing category: NDA
Marketing start: 2021-11-04
Marketing end: 0000-00-00
Substance: AMPHETAMINE
Active strength: 5 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule: CII
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	27808-106	27808-106-01	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N210526-001	DYANAVEL XR 5	AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04
N210526-002	DYANAVEL XR 10	AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04
N210526-003	DYANAVEL XR 15	AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04
N210526-004	DYANAVEL XR 20	AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210526-001	8337890	2027-03-15		Drug product	2021-11-22
N210526-001	8747902	2027-03-15		Drug product	2021-11-22
N210526-001	9675704	2027-03-15		Drug product	2021-11-22
N210526-001	11590081	2038-09-24	U-3538	Drug product	2023-03-08
N210526-001	12458592	2040-02-11	U-3538		2025-11-14
N210526-002	8337890	2027-03-15		Drug product	2021-11-22
N210526-002	8747902	2027-03-15		Drug product	2021-11-22
N210526-002	9675704	2027-03-15		Drug product	2021-11-22
N210526-002	11590081	2038-09-24	U-3538	Drug product	2023-03-08
N210526-002	12458592	2040-02-11	U-3538		2025-11-14
N210526-003	8337890	2027-03-15		Drug product	2021-11-22
N210526-003	8747902	2027-03-15		Drug product	2021-11-22
N210526-003	9675704	2027-03-15		Drug product	2021-11-22
N210526-003	11590081	2038-09-24	U-3538	Drug product	2023-03-08
N210526-003	12458592	2040-02-11	U-3538		2025-11-14
N210526-004	8337890	2027-03-15		Drug product	2021-11-22
N210526-004	8747902	2027-03-15		Drug product	2021-11-22
N210526-004	9675704	2027-03-15		Drug product	2021-11-22
N210526-004	11590081	2038-09-24	U-3538	Drug product	2023-03-08
N210526-004	12458592	2040-02-11	U-3538		2025-11-14

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 4 · 132 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	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210526-001	DYANAVEL XR 5	4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210526-002	DYANAVEL XR 10	8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210526-003	DYANAVEL XR 15	12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2021-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210526-004	DYANAVEL XR 20	16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2021-11-04	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 500 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210526-001	8337890	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-001	8747902	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-001	9675704	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-001	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-001	12458592	2040-02-11	U-3538		2025-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-002	8337890	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-002	8747902	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-002	9675704	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-002	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-002	12458592	2040-02-11	U-3538		2025-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-003	8337890	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-003	8747902	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-003	9675704	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-003	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-003	12458592	2040-02-11	U-3538		2025-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-004	8337890	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-004	8747902	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-004	9675704	2027-03-15		Drug product	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-004	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210526-004	12458592	2040-02-11	U-3538		2025-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-001	8337890	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-001	8747902	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-001	9675704	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-001	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-001	12458592	2040-02-11	U-3538		2025-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-002	8337890	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-002	8747902	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-002	9675704	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-002	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-002	12458592	2040-02-11	U-3538		2025-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-003	8337890	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-003	8747902	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-003	9675704	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-003	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-003	12458592	2040-02-11	U-3538		2025-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-004	8337890	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-004	8747902	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-004	9675704	2027-03-15		Drug product	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-004	11590081	2038-09-24	U-3538	Drug product	2023-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210526-004	12458592	2040-02-11	U-3538		2025-11-14	`31067a03dcf5…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMPHETAMINE	ACTIVE INGREDIENT	CK833KGX7E	DYANAVEL XR (AMPHETAMINE) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]	2
AMPHETAMINE	ACTIVE MOIETY	CK833KGX7E	DYANAVEL XR (AMPHETAMINE) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	DYANAVEL XR (AMPHETAMINE) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DYANAVEL XR (AMPHETAMINE) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	DYANAVEL XR (AMPHETAMINE) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]	2
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)	INACTIVE INGREDIENT	461P5CJN6T	DYANAVEL XR (AMPHETAMINE) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DYANAVEL XR (AMPHETAMINE) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]	2
POLYVINYL ACETATE	INACTIVE INGREDIENT	32K497ZK2U	DYANAVEL XR (AMPHETAMINE) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	DYANAVEL XR (AMPHETAMINE) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	DYANAVEL XR (AMPHETAMINE) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DYANAVEL XR (AMPHETAMINE) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]	2
SODIUM POLYSTYRENE SULFONATE	INACTIVE INGREDIENT	1699G8679Z	DYANAVEL XR (AMPHETAMINE) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	DYANAVEL XR (AMPHETAMINE) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	DYANAVEL XR (AMPHETAMINE) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	DYANAVEL XR (AMPHETAMINE) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]	2

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
Dyanavel XR	AMPHETAMINE	NextWave Pharmaceuticals, Inc	ae304b29-0b40-40ec-ad0d-76b742d4a9b9	2026-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 210526 application number: NDA210526

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CK833KGX7E	AMPHETAMINE	300-62-9	AMPHETAMINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
27808-106-01	27808010601	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (27808-106-01)	2022-02-28	0000-00-00	No	No	Current